Apex Life Sciences

Apex Life Sciences Chatsworth, Los Angeles, CA, USA
Aug 16, 2019
Full time
General Description: Identify, develop and maintain quality systems to ensure continuous improvement throughout the company in the management of audits to meet customer, regulatory and cGMP requirements. Work with cross-functional teams to facilitate and lead quality improvement activities. Specific Duties and Responsibilities: Ensure adherence to Quality System, and update SOP and Departmental Procedures as necessary. Support internal and external audit programs. Assist in development of checklists and participate in facility walk-throughs. Document and incorporate observations into tracking logs for communication to relevant functions. Develop and maintain general audit documentation, and ensure appropriate employee training conducted and completed as required. Provide timely corrective action to audit findings and coordinate meetings to follow up with responsible parties for completion of actions are within established timelines. Develop and monitor effectiveness checks upon completion of audit related Corrective and Preventive Action (CAPA). Work with cross-functional teams to establish and maintain monthly metrics and KPIs for Quality; use data to drive improvements. Ensure timely completion of reports including Non-Conformance Reports (NCR), Quality Alerts (QAR), and Quality deviations. Help relevant teams develop appropriate short and long term actions to address quality outages. Create & maintain cohesive company information management pertaining to Quality (employee training documentation, equipment calibration master list, etc.). Support the Executive Director of Quality & Regulatory on other special projects. Educational Requirements: Bachelor of Science in chemistry/related field, or combination of education and experience in cosmetics or related (FDA regulated) industry are required. Qualifications: Minimum 3-5 years of experience in Quality in an FDA regulated environment preferred. Experience with OTC or pharmaceutical products preferred. Must be extremely detail oriented. Must be able to work on numerous simultaneous projects to meet established timelines. Excellent verbal and written communication skills required.
Apex Life Sciences San Carlos, CA, USA
Aug 16, 2019
Full time
Quality Engineer Opportunity. Position Summary Quality Engineer III supports the quality system processes of the CLIA laboratories and activities associated with CE-IVD kits and software. The QE III works with QE Manager/QA Director to address supplier issues, nonconformances and corrective actions that impact the CLIA laboratory operations. This position will also represent QA on product development projects. Primary Responsibilities Support internal and external audits (CLIA/CAP, ISO 13485, customer) Responsible for CAPA, Deviation, Change Requests and Nonconformance investigation and reporting Write/revise procedures and forms; submit to Document Control and assist with training as needed Perform statistical analysis/hypotheses testing (AQL's etc.) as required Support Quality systems compliance to CLIA, FDA QSR, ISO 13485, and HIPAA Participate in the management of Approved Suppliers Follow established company standard operating procedures and good documentation practices Review manufacturing/QC batch records Other duties as assigned Qualifications Position requirements are a B.S. or equivalent in science, engineering or related field At least 6 years of experience in medical diagnostic, CLIA laboratory, or Life Sciences industry; 3 years' experience in a quality role Audit experience - internal audits, third party audits and/or regulatory audits American Society of Quality certifications (CQE) preferred FICATIONS Knowledge, Skills, and Abilities Knowledge of CLIA/CAP regulations, ISO 13485 standard and/or FDA QSRs (21 CFR 820) Computer skills (MS Word, Excel, PowerPoint, etc.) Good technical writing and communication skills Independent worker, a self-starter with strong organizational and planning skills Has an ability to be productive and successful in an intense work environment Preferred skills: Hands on experience with DNA Isolation and Purification, PCR, Cell Culture, Sequencing, Bioinformatics etc. Demonstrated good judgment, excellent attention to detail, excellent written, verbal communication and interpersonal skills are desired with the ability to be flexible and collaborate on multiple projects Physical Demands and Work Environment Duties typically performed in an office setting Must be able to sit or stand for long periods of time
Apex Life Sciences Menlo Park, CA, USA
Aug 14, 2019
Full time
Our client, an established Immuno-oncology company in the South Bay is looking to add qualified CLS's to their growing team. Summary The Experienced Clinical Laboratory Scientist is responsible for testing and reporting clinical laboratory results. Responsibilities Performs and reports laboratory testing on clinical laboratory samples used to aide physicians in the diagnosis and treatment of patients Selects, implements, and evaluates results for Quality Control materials used in statistical process control of laboratory assays Troubleshoots assays and equipment for which QC materials fail to perform adequately Participates in activities required to support all necessary licensure for the clinical laboratory, including quality management functions and on-site inspections of the laboratory Responsible for maintaining updated understanding and knowledge of the methods employed in the laboratory and the use of the resulting information by physicians through continuing education activities Trains other CLS personnel and other staff in laboratory methods. May be required to monitor the activities of non-licensed personnel May be required to supervise the activities of the laboratory in the absence of an on site manager May be required to assist in assay development activities. The testing personnel are responsible for specimen processing, test performance and for reporting test results Each individual performs only those high complexity tests that are authorized by the laboratory director and require a degree of skill commensurate with the individual's education, training or experience, and technical abilities Each individual performing high complexity testing must - Follow the laboratory's procedures for specimen handling and processing, test analyses, reporting and maintaining records of patient test results Maintain records that demonstrate that proficiency testing samples are tested in the same manner as patient specimens Adhere to the laboratory's quality control policies, document all quality control activities, instrument and procedural calibrations and maintenance performed Follow the laboratory's established policies and procedures whenever test systems are not within the laboratory's established acceptable levels of performance Be capable of identifying problems that may adversely affect test performance or reporting of test results and either must correct the problems or immediately notify the general supervisor, technical supervisor, clinical consultant, or director Document all corrective actions taken when test systems deviate from the laboratory's established performance specifications Education / Experience California Clinical Laboratory Scientist license in categories appropriate for the area of testing performed Minimum of 1 year of experience in a clinical laboratory setting; preferably with experience in a high complexity molecular testing environment Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.
Apex Life Sciences San Diego, CA, USA
Aug 13, 2019
Full time
Our client is currently focused on utilizing its proprietary E-CEL technology as a direct therapeutic product for improving Hematopoietic Stem Cell Transplants (HSCTs), as well as offering a novel therapy for the regeneration of damaged tissues resulting from both acute and chronic disease. Research Scientist, In Vivo Research & Engineered Cell Biology Position Role & Responsibilities: Conduct pre-clinical in vivo studies, some requiring microsurgery, which test our pre-clinical engineered cell product candidates Analyze data collected from in vivo studies performed Participate or lead in design of in vivo studies Conduct and analyze 2-D and 3-D engineered cell culture and assay experiments relevant to engineered cell product candidates Works collaboratively with fellow AB team members, especially with the AB Research Team and the AB Project Management Team Education/Requirements: Master's degree or PhD in cell biology, molecular biology, biochemistry, immunology or related field and 5 or more years post-graduate hands-on laboratory experience (post-doc or industry experience) covering both in vitro and in vivo work. Enjoys a fast-paced environment where data-based changes are a constant and where proactive 'can do' attitude, sense of urgency and friendly personalities are prized. A track record of the ability to learn new in vivo surgical and modelling techniques is essential Possesses skills related to wet-lab cell-therapy translational research Various cell culture techniques, cell sorting, flow cytometry, qPCR, fluorescent microscopy, antibody assays, intra-cellular signaling detection). A successful candidate must have extensive hands-on experience in performing in-vivo animal modelling work for various potential indications. Previous experience with the following in vivo procedures: Tissue extraction and dissection, IV injection (tailvein, jugular, retro-orbital) and surgical proficiency in murine models (not limited to a specific area: e.g. intratracheal administration, partial hepatectomy, partial pneumonectomy, vascular ligation and/or thrombosis, gastrointestinal and/or vascular anastamoses, etc) Additional Desired Skills and Knowledge. Applicants with experience in various micro-surgical procedures in murine models. The applicant's ability to not only perform such surgical procedures, but also demonstrate knowledge and experience in designing such in vivo experiments would be highly regarded. Applicants with expertise in organ regeneration modelling related to inflammatory and autoimmune disease and injuries would also be preferred. Preference for candidates with experience in the fields of tissue regeneration and/or microvascular biology and vascular niches. Demonstrated expertise in translational in vivo cellular biology involving research and/or product development of cell therapy product is highly desired.
Apex Life Sciences South San Francisco, CA, USA
Aug 12, 2019
Full time
Senior Research Associate, Cell Culture Research Location: South San Francisco, CA Job Description . We are looking for a highly motivated individual to contribute towards the development of therapeutics for treating degenerative diseases. The candidate must have extensive experience in mammalian cell culture including specific experience with stem cell culture and differentiation protocols. The position requires excellent written and verbal skills. Candidate must be highly organized, detail oriented with excellent data collection and data management skills. As a tissue culture research associate at Stratacuity, you'll work under the supervision of our Senior scientist to support and expand Stratacuity cell engineering program. Essential Job Functions and Job Requirements: Small and large-scale culture of mammalian and stem cell lines Generation and differentiation of iPS-cell derived cell lines Participate in the design and optimization of co-culture models Perform cell-based assays such as migration, proliferation, apoptosis and endocytosis Manage material inventory for all cell culture activities Manage more than one type of cell culture at a given time Troubleshoot complex problems in creative and effective ways; actively participate with innovation and/or optimization of established processes to ensure project timelines are met. Compile, process and analyze data; record research procedures and results; file and maintains records. Qualifications BS/MS in Biology, Neuroscience, or related field. 2-5 years with BS or 0-2 years with MS of biotechnology industry experience required. Experience in cell processing and harvest Demonstrated ability to perform technical manipulations using aseptic technique Prior work with mammalian tissue culture practices including iPS -derived cultures is required Proficiency in developing and running-in vitro cell-based functional assays 3D culture and organoid culture experience is preferred Experience in immunology, immunostaining is desirable A strong interest in developing treatments for neurodegenerative diseases Well organized, detail-oriented data collection and data management Excellent written and verbal communication skills Ability to do scientific work independently as well as part of a team, to multitask and demonstrate flexibility, and to meet deadlines in a fast-paced and energetic start-up environment Stratacuity is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status, or any other characteristic protected by law.
Apex Life Sciences San Carlos, CA, USA
Aug 11, 2019
Full time
The Senior Product Manager leads the development and commercialization of future versions of on-market or new product lines including new features and service components of products. This person supports the vision and strategic product roadmap for certain products with the goal of extending its leading market share and value proposition. The Senior PM is responsible for the entire product lifecycle from concept to obsolescence, evaluation, and prioritization of new features and programs, a creation of product requirements and monitoring product performance in the field. The role combines strategic thinking with execution and will require a strong cross-functional leader and influencer. PRIMARY RESPONSIBILITIES Develop and execute the product roadmap. Deliver product requirements based on customer needs and operational limitations. Manage product performance and field all product support needs, working across departments, including Product Management, Molecular Biology R&D, Statistics R&D, Software Engineering, Sales & Marketing, Clinical/Medical, Operations, Regulatory, and Business Development. Develop quantitative product performance indicators, analyze and track performance data, and identify strategies for improvement across teams. Identify business opportunities and create business cases and financial models. Conduct VOC interviews, market research, and competitive analysis as a means to test and validate product features, improve customer satisfaction and support market growth. Support product marketing in the definition of product positioning - from market launch plans, pricing, and delivering key collateral content to marketing communications. Create written, data-based arguments and presentations to achieve buy-in from stakeholders Provide internal and external stakeholders with the appropriate updates on progress, vision, product roadmap, etc. QUALIFICATIONS Bachelor's degree required, preferably in physical or life science, statistics, engineering discipline, or equivalent. Master's degree preferred. Minimum of 8 years of experience, which includes 4-5 years of product management, product/solution marketing, product commercialization, or strategic consulting experience. Experience with Prenatal products/education, medical devices, or diagnostics preferred. Expertise and experience in the Life Sciences industry preferred. KNOWLEDGE, SKILLS, AND ABILITIES Ability to lead and motivate a cross-functional team Ability to understand technology and articulate customer value/benefit propositions Basic financial/economic modeling skills Proven excellence in both written and oral communications skill Ability to collaborate and interact effectively with individuals, and influence individuals across functional areas and in team environments. Proven organizational skills and extraordinary attention to detail, with an ability to manage multiple tasks simultaneously. Demonstrated experience influencing larger groups and leading a team in a successful project. Will consider scientific or technical project leads for candidates coming from research and development roles. PHYSICAL DEMANDS AND WORK ENVIRONMENT Duties are typically performed in an office setting. This position requires the ability to use a computer keyboard, communicate over the telephone and read printed material. Duties may require working outside normal working hours (evenings and weekends) at times.
Apex Life Sciences Berkeley Heights, NJ, USA
Aug 11, 2019
Full time
CLINICAL PROGRAMMER LEAD Clinical Data Design, Rave, Inform, Oracle Clinical) Responsibilities: Develop, program, test and maintain clinical trial databases and data entry screens using Rave in accordance with internal standards Lead collaborative cross-functional team study build meetings for in-house and outsourced studies Review edit checks for in-house and outsourced studies Perform external data loads, i.e., labs, ECGs, etc., as needed. Act as liaison with vendors to establish transfer specifications and internal standards Participate in and lead team meetings when appropriate Act as primary CRO contact, when necessary, to ensure that internal standards are implemented in all studies Provide technical expertise and support to Data Management team Control access to database and perform snapshots, database lock and freeze activities Make data, including interim data, available to company personnel and regulatory agencies when required Perform post processing of data extracts in accordance with internal standards to be delivered to Biostatistics Routinely interface with cross-functional team members Influences other functions and represents as DBO technical expertise Internal team leader who decides best course of action Coach and advise junior programmers to identify problems and solutions Review clinical programming activities and costs in contracts Assess CRO data management systems for regulatory compliance Interact with CROs in the design and development of databases that are compatible with company needs Monitor progress of clinical programming activities in CROs Participate in regular team meetings and provide input when appropriate Participate in the development of clinical programming SOPs and the development/optimization of clinical programming processes from study start up to database lock. Routine interface with cross-functional team members in creating an appropriate database, data quality assurance, and support of data cleaning activities Direct responsibility for supervising and training junior clinical programmers in the performance of their duties Managing project priorities and timelines Qualifications: BS/BA degree or equivalent in a relevant scientific discipline with 5+ years related Clinical experience Advanced knowledge of clinical database design is a must (Rave, Inform, Oracle Clinical or other systems). Safety Gateway, TSDV, Site Payments and Coder experience a plus Good communication skills; ability to work in a team environment with data managers, medical personnel, clinical monitors, statisticians, programmers, and medical writers Knowledge of FDA/ICH guidelines and industry standard practices regarding programming desired Medical or mathematics/computer science background a plus Detailed knowledge and experience in case report form design, central laboratories, programming databases, query resolution, data validation Knowledge of clinical trial design and basic statistics a plus Technical project management experience a strong plus Computer skills: knowledge of MS Office program suite
Apex Life Sciences South San Francisco, CA, USA
Aug 10, 2019
Full time
Responsibilities Design and perform proof-of-mechanism as well as proof-of-concept gene editing studies. Hands-on execution of in vitro, ex vivo, and in vivo assays to analyze gene editing of development candidates. Perform cell biology, molecular biology, and biochemistry analyses. Analyze, interpret, and present experimental data. Collaborate with colleagues to ensure timeline adherence and project alignment to meet group and company goals. Support external and internal projects via team meetings, presentations, and reports. Attention to detail and ability to operate independently. Excellent communication and record keeping skills. Essential Qualifications A PhD degree, or equivalent, with 3-5 years of post-doctoral training or industrial experience. Strong background in mammalian gene therapy/editing, RNA biology, DNA repair or related fields. Hands-on experience with a broad range of cell and molecular biology techniques. Experienced with mammalian cell culture (primary cells and cell lines), transient transfections, standard molecular cloning techniques, and cell-based assays. Ability to multitask and readily adapt to change. Preferred Qualifications Familiarity with the field of hematopoiesis and hematological diseases. Experience manipulating primary human hematopoietic cells. Experience with gene-editing (CRISPR/Cas9, ZFNs, TALENs) and DNA/RNA/protein delivery. Knowledge in DNA repair mechanisms and pathways. Broad conceptual expertise with genomics technologies and hands-on expertise with assays including microarray analyses, digital PCR and QPCR, and next-gen sequencing. Experience in FACS, Luminex multiplex assays, and IHC/ICC/IF.
Apex Life Sciences South San Francisco, CA, USA
Aug 09, 2019
Full time
Our client is a late-stage biopharmaceutical company focused on discovering, developing, and commercializing first-in-class muscle activators as potential treatments for people with debilitating diseases in which muscle performance is compromised and/or declining. As a leader in muscle biology research, they are developing small molecule drug candidates specifically engineered to increase muscle function and contractility. Responsibilities: This individual will support skeletal and cardiac muscle programs by running high-throughput biochemical and/or cellular assays for hit identification and lead optimization. Execute electrophysiology experiments for assessment of lead molecules in adult rodent primary cardiomyocytes and run specialized muscle assays, crunch data and generate reports The candidate will use data analysis software to analyze large datasets, generate integrated data analysis reports, and provide results to stakeholders in a timely manner. This individual will work closely with our engineering team to optimize and troubleshoot automation workflow processes. Qualifications: The position requires a BS/MS in biochemistry, cell biology or related field with 3-5 years of research experience in a pharmaceutical, or biotechnology setting. Experience in adult rodent cardiomyocyte isolation preferred Prior experience in biochemical and/or cell-based assay development, execution including data analysis and reporting, is required Familiarity with automation systems, liquid handling devices and experience with data analysis and visualization software Spotfire including Excel, GraphPad, Abase is preferred Quick learner, demonstrate initiative and accountability Strong organizational and time management skills, attention to detail and flexibility Ability to work independently and in a team-based, multi-disciplinary environment
Apex Life Sciences Milpitas, CA 95035, USA
Aug 09, 2019
Full time
Our Client, a bay area leader in stem cell research and specialty genome services is looking for a motivated microinjection specialist. This position is responsible for the animal model division, conducting transgenic animal production through microinjection of DNA/RNA/protein into pronuclear stage embryos or making chimeric animals with injection of targeted ESCs into morula/blastocysts. Skills and Experience Bachelor degree in Biological Sciences or Animal Science. Master degree in the related field preferred. Strong understanding of mammalian genetics. Proficient in transgenic production including rodent handling, sampling, microinjection, embryo transfer, IVF, and gamete/embryo cryopreservation. Minimum of one-year of microinjection experience, such as a weekly injection in an institutional transgenic core. Industry experience preferred. Extensive experience with animal survival surgery. Familiar with general lab operations such as pipetting, centrifuge, and biohazardous disposal etc. Strong organizational and documentation skills Effective verbal and written communication skills. Team player. Proficient at MS Office. Duties and Responsibilities Responsible for daily projects running with animal superovulation, embryo harvesting, microinjection, and embryo transfer to pseudo pregnant recipients. Carry out IVF, cryopreservation, and associated procedures for R&D and service projects. Assist with animal colony management including tracking animal pregnancy, wean, and setting up breeding. Organize and maintain laboratory notebooks and records including methods, procedures, protocols, reports, samples log and storage, and data storage. Work according to safety regulations and facility protocols. Support other departments as needed.
Apex Life Sciences Novato, CA, USA
Aug 08, 2019
Full time
Position Summary: This role is responsible for administrative and project based tasks within the Quality Assurance department. The Quality Assurance Associate role is pivotal in the daily functions of the Quality operation within a growing organization and meticulous attention to detail is a key to success in this role. The Quality Assurance Associate is primarily responsible for the Batch Record Review and Document Control processes at Stratacuity. This position is a full-time, non-exempt role that reports to Quality Management. Areas of Responsibility : Review of batch production records for completeness and release Review of analytical records and any supporting documentation to ensure compliance with cGMPs and LGC Biosearch policies and procedures. Be well versed in the requirements of ISO 9001, ISO 13485, 21 CFR 820 and other applicable regulations. Perform routine document control activities including creation and/or revision, processing, routing and review. Work with various departments to set up appropriate documentation to improve efficiency and accuracy. Assists in performing QC data review for batch record in-process and final QC approval. Assist with internal Quality audits of internal departments, as necessary. Assisting Quality Management with various projects, including but not limited to the trending of Quality Objective data and CAPA maintenance. May be called upon to assist with the Supplier Qualification program. Provide guidance and train others on Quality System and Quality Assurance procedures. Perform additional tasks, as assigned Experience with Batch Record Review, Product Disposition and Document Control. Familiarity with ISO 9001:2008, ISO 13485:2003 and 21 CFR 820. Excellent people, verbal, and communication skills. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Must have solid teamwork skills to interface with engineers, chemists, technicians and analysts to ensure smooth laboratory and plant operations. Self-motivated individual who can work in a multi-disciplinary team. Good troubleshooting, communications, and teamwork. Education/Experience: Bachelor's degree
Apex Life Sciences Richmond, CA, USA
Aug 05, 2019
Full time
Administrative Assistant Essential Functions: Answer all incoming calls and route as appropriate and takes messages. Check company voice mail every morning. Route and respond to messages appropriately and delete messages once routed so that the mail box is never full. Welcome visitors/interviewees and announce their arrival to appropriate person. Maintain security by following procedures; monitoring logbook; issuing visitor badges; providing NDA disclosures and obtain signatures from all visitors. Be back up to distribute office mail when HR Assistant and/or Facilities are not available. Responsible for weekly office supply order. Will coordinate with administrative staff on office supply needs. Review order carefully so as to limit incorrect supplies. Work with /Facilities to inventory Costco supplies and to adjust orders accordingly so that inventory levels are appropriate. Responsible for making sure the Costco order is placed weekly which includes the fruit, milk, cheese and monthly snacks. Put the fruit out in Suite F, provide fruit to HR admin to be distributed in Suite A and to Tech Ops Admin to distribute in West Cutting. Main contact for catering and lunch requests. Prepare refreshments and order food for meetings. Assist HR team in scheduling meetings, travel and interview coordination. Assist G&A management team in preparing expense reports. Upkeep of general conference room scheduling, set up and clean up. Ensure all conference rooms are cleaned after the lunch meetings. Create bulletin board announcements for birthday socials, anniversaries, new hires and job postings by comparing the excel reports and announcements provide by HR. May be asked to assist Human Resources with non-confidential filing as needed. Daily tasks and assistance will be assigned by HR Rep as needed to assist HR events and operations. Education, Experience and Skills Requirements: High School Diploma or equivalent, College graduate a plus. A minimum of one to three years of relevant experience Experience using multi line telephone systems Consistent attendance and punctuality is essential for this position to be successful Fluent in Microsoft Office suite applications, particularly Outlook Calendar. Superior oral and written communication skills, attention to detail, professional and creative approach to problem resolution, strong organizational skills, ability to prioritize projects and ability to take initiative Knowledge of general clerical/office systems and office organization required Ability to work with confidential and sensitive data Professional demeanor and positive attitude about work and providing service
Apex Life Sciences San Francisco, CA, USA
Aug 03, 2019
Full time
Job Function Summary : Involves managing or performing the administrative services or managing the full general operations of an academic or non-academic organization(s). Administrative services include activities in finance and human resources and may also include IT, facilities, or student services. General management activities include long and short range strategic planning in determining the mission and directing all activities of multidisciplinary departments through subordinate management staff. Custom Scope The IND Laboratory Coordinator is a newly created position in our department resulting from significant growth in our faculty size and research output. The incumbent will assist, and be supervised by, the current IND Laboratory Manager who manages a large (approx. 26k square foot) biological lab (BSL2 and BSL3) in the Sandler Neurosciences Center building on the Mission Bay campus. The Lab Coordinator responsibilities will be primarily operational in the laboratory and will parallel those of the Lab Manager, with less overall responsibility. Generally, the Lab Coordinator responsibilities will involve sustentation of the lab's facilities, resources, equipment and lab operations, including, but not limited to: renewal and modification of Biological User Authorizations (BUAs) for BSL2 and 3 labs, updating the Biosafety Manual, interacting with EH&S/USDA/CDC, contract reviews, regulatory reviews, facilities-related requests, some lab supplies and equipment ordering, inventory management, lab personnel training follow-up, overall lab maintenance, and general lab safety and compliance. Department Overview Stratacuity is pursuing a cutting-edge blend of basic science and clinical medicine to provide outstanding care to those suffering from neurodegenerative diseases. Founded in 1999, the IND is committed to creating therapeutics that will halt diseases such as Alzheimer's, Parkinson's, Creutzfeldt-Jakob disease and dementia resulting from traumatic brain injuries. The IND is poised to make serious contributions to this struggle at the frontier of neuroscience and medicine. The mission of the Institute for Neurodegenerative Diseases is to discover causes and develop cures for these illnesses with an innovative program of basic research and clinical medicine. The IND is directed by Nobel Laureate Stanley Prusiner, MD.
Apex Life Sciences South San Francisco, CA, USA
Aug 03, 2019
Full time
Senior Chemist Position Summary Stratacuity is a stealth-mode therapeutics development company pioneering a novel synthetic gene editing technology to treat and cure patients with devastating rare diseases. We seek a motivated and collaborative chemist to join our team. Candidates should have a Bachelor's degree in organic chemistry with minimum of 4 years of industry experience (or minimum 2 years of experience in case of master's degree in organic chemistry) in the field of organic or peptide synthesis. The successful candidate will be part of a dynamic and rewarding work environment where the abilities to effectively communicate and function in a team environment will be essential for success. Responsibilities Successfully prepare, purify and characterize peptide nucleic acid oligomers for Stratacuity's research efforts toward therapeutics development for rare diseases using gene editing technology Maintain PNA monomer and oligomer inventory and Preparing PNA aliquots for delivery to different groups for research purpose Labelling of PNA probes via solution and solid phase methodologies Use and maintain the team's peptide synthesizers, HPLCs, Q-TOF and other instruments for synthesis workflow Development, submission, and maintenance QC data on files as well as on internal database Planning, execution, and documentation of work under the guidance of the lead chemist Independent work on projects and presentation in team meetings Essential Qualifications Bachelor's degree with 4 years of industrial experience respectively in the field of organic or peptide synthesis Hands on experience in the HPLC analysis and purification Excellent communication and record keeping skills Ability to multitask, able to work in a team and readily adapts to changing priorities Preferred Qualifications Master's degree in Chemistry with minimum 2 years of industrial experience respectively in the field of organic or peptide synthesis experience using automated peptide synthesis instrumentation Experience with LC-MS, especially LC coupled with Q-TOF Hands on experience on preparative scale purification of peptides or oligos
Apex Life Sciences Brisbane, CA, USA
Aug 02, 2019
Full time
Essential Functions: Answer all incoming calls and route as appropriate and takes messages. Check company voice mail every morning. Route and respond to messages appropriately and delete messages once routed so that the mail box is never full. Welcome visitors/interviewees and announce their arrival to appropriate person. Maintain security by following procedures; monitoring logbook; issuing visitor badges; providing NDA disclosures and obtain signatures from all visitors. Be back up to distribute office mail when HR Assistant and/or Facilities are not available. Responsible for weekly office supply order. Will coordinate with administrative staff on office supply needs. Review order carefully so as to limit incorrect supplies. Work with /Facilities to inventory Costco supplies and to adjust orders accordingly so that inventory levels are appropriate. Responsible for making sure the Costco order is placed weekly which includes the fruit, milk, cheese and monthly snacks. Put the fruit out in Suite F, provide fruit to HR admin to be distributed in Suite A and to Tech Ops Admin to distribute in West Cutting. Main contact for catering and lunch requests. Prepare refreshments and order food for meetings. Assist HR team in scheduling meetings, travel and interview coordination. Assist G&A management team in preparing expense reports. Upkeep of general conference room scheduling, set up and clean up. Ensure all conference rooms are cleaned after the lunch meetings. Create bulletin board announcements for birthday socials, anniversaries, new hires and job postings by comparing the excel reports and announcements provide by HR. May be asked to assist Human Resources with non-confidential filing as needed. Daily tasks and assistance will be assigned by HR Rep as needed to assist HR events and operations. Maintains safe, clean and professional reception area by complying with procedures, rules and regulations. Other projects may be required and will be assigned on an as needed basis. Education, Experience and Skills Requirements: High School Diploma or equivalent, College graduate a plus. A minimum of one to three years of relevant experience Experience using multi line telephone systems Consistent attendance and punctuality is essential for this position to be successful Fluent in Microsoft Office suite applications, particularly Outlook Calendar. Superior oral and written communication skills, attention to detail, professional and creative approach to problem resolution, strong organizational skills, ability to prioritize projects and ability to take initiative Knowledge of general clerical/office systems and office organization required Ability to work with confidential and sensitive data Professional demeanor and positive attitude about work and providing service
Apex Life Sciences Newbury Park, Thousand Oaks, CA, USA
Aug 01, 2019
Full time
Top Requirements: Strong project management skills Be self-motivated Able to interface effectively with various levels Attentive to details and able to prioritize and meet deadlines, and must possess excellent leadership, Problem solving, analytical, influencing and customer service skills to operate and deliver results in a matrix-managed GMP environment Daily Responsibilities: Supporting the product complaint system at Client through; leading and managing product complaint investigations, performing data analysis and trending of complaint information to proactively detect signals and take appropriate actions in a timely manner. - Keep the complaints database updated as soon as factual information is available and summarize closed investigations into the database accurately. Ensure complaint related investigations are concise, clear and science-based by reviewing and approving such investigations. Follow-up on corrective actions derived from investigations through completion. Conducting and documenting the investigation. May also include: Communication and escalation of complaints, site representation on the product complaint network and generation and issuance of closure letters to patients and business partners. Other duties as assigned
Apex Life Sciences Santa Rosa, CA, USA
Aug 01, 2019
Full time
Description: This is a senior level position that requires 5-10 years project management experience. This position will: - Leads one or more projects of varying complexities, facilitating the full spectrum of project management processes MAIN DUTIES: 1. Provides project management expertise for small and large scale programs. a. Leads a multi-functional teams from Concept through Launch; through proper execution of project planning and schedule execution b. Works closely with various disciplines within IT, Laboratory Operations, Sales and establishes program plans and objectives. c. Develops cost analysis, creates and manages the integration of project schedules, program budget. d. Tracks progress and communicates proactively the impact of changes (e.g. scope, cross functional resources, timelines, costs, etc.) to key stakeholders. OTHER RESPONSIBILITIES: 1. Leads the teams through best practices in planning such as creating work breakdowns, schedule development, and critical path analysis 2. Execute detailed business case development and analysis to support project justification. Highly skilled in the use of MS Excel. 3. Prepare power point presentation for communicating analysis models and project status information. Preferred educational background: BS in Business or another related field of study PMP certification preferred Preferred experiential background: At least 5 years' experience in progressively more responsible Project/Program roles. Project Management or similar certification required. Must be highly organized, detail-oriented and have prior project / program management experience. Must possess exceptional abilities in relationship building and be a team player who with effective communication / listening skills. Hands-on project experience in a clinical and/or laboratory setting is highly desired. All listed tasks and responsibilities are deemed as essential functions to this position; however, reasonable accommodations will be made if at all possible under business conditions.
Apex Life Sciences San Francisco, CA, USA
Aug 01, 2019
Full time
The Senior Scientist, Analytical Development will be responsible for developing analytical techniques to support drug substance and drug product formulation development activities. Responsibilities: Develop analytical techniques to support drug substance process and drug product formulation development activities Manage analytical method development to support characterization of drug substance and drug products Apply scientific principles in selecting appropriate techniques for development of sensitive and robust methods Troubleshoot analytical methods, hardware and software issues arising at CROs/CMOs Research new techniques and recommend alternative approaches and potential solutions to analytical issues Write analytical test methods, protocols and reports as part of analytical transfers to CROs/CMOs for GMP testing Contribute to authoring of CMC sections to support regulatory filings Serve as an analytical subject matter expert within department and cross-functional areas Qualifications: Ph.D in analytical chemistry or related disciplines, with at least 5 years relevant experience in pharmaceutical industry Skills, Knowledge & Abilities: Extensive knowledge and hands-on experience on chromatographic and spectroscopic techniques (e.g. GC, HPLC, MS, UV/Vis) Knowledge of techniques required for physicochemical characterization of drug substance (e.g., particle size, TGA, DVS, DSC etc.) Experience with analytical method validations and transfers in regulated environments is required Experience with development and validation of methods for bioassay to determine potency is a plus Attention to detail and excellent analytical skills as applied to data review and investigations Passion for learning, creating, relating, communicating, and leading cross functional teams Excellent verbal and written communication skills Experience in a start-up environment preferred Must be pro-active team player, flexible, and open to change
Apex Life Sciences San Carlos, CA, USA
Jul 31, 2019
Full time
Our client is a leader in women's health through genetic screenings. They are transforming therapeutics and changing lives. POSITION SUMMARY: The Associate Clinical Variant Curator is an independent role in the interpretation of results for clinical DNA specimens for diagnosing genetic disease, using manual and automated methods in a team environment, and following established policies and procedures, in a professional manner. Additionally, aides the laboratory director during the test development and validation of clinical testing pipelines. The associate curator cultivates excellent working relationships with Research and Development, Process Development and Operations, Genetic Counseling, LIMS support engineering and the biostatistics and bioinformatics teams. PRIMARY RESPONSIBILITIES: Efficiently reviews data (ABI, NGS, MLPA, etc.) and approves results according to standard procedures. Efficiently evaluates and provides assessment of pathogenicity for detected DNA sequence variants and/or DNA Copy Number Variations (CNV). Assists in the development of procedures for classifying genetic variation according to ACMG/AMP guidelines, curation in internal databases, submission to ClinVar, and for publication. May assist in the instruction of trainees in the CLS training program and/or other duties as assigned. This role works with PHI on a regular basis both in paper and electronic form and has access to various technologies to access PHI (paper and electronic) in order to perform the job. Employee must complete training relating to HIPAA/PHI privacy, General Policies and Procedure Compliance training and security training as soon as possible but not later than the first 30 days of hire. Employee must pass post offer criminal background check. QUALIFICATIONS: Masters in a Life Science such as Molecular Biology/Genetics/Bioinformatics/Biochemistry or equivalent; PhD preferred. A minimum of 3 years of ABI, NGS, MLPA data interpretation experience. Clinical laboratory experience in human genetics required. KNOWLEDGE, SKILLS, AND ABILITIES: A strong background in Human Genetics is essential. In-depth understanding of the biology, molecular mechanisms and functional studies of human genetic disease genes is necessary. Ability to critically read, understand, and interpret data from scientific publications on a daily basis is required. Cross-disciplinary and strong analytical skills as well as broad experience using computational methods, databases, software and hardware. Familiarity with NCBI and other germline databases, Sanger Sequencing and Next-generation sequencing (NGS) is strongly preferred Technical skills include a knowledge of elementary statistics, interpretation of graphs and quick grasp of scientific data. Ability to perform a "paper chase" through the scientific literature to understand the significance of a particular human variant. Ability to provide succinct written and verbal summaries of medical and scientific literature. Computer literacy required. Ability to interact favorably with large cross-functional teams and get along with and prosper working in a diverse group of people is required. Ability to read, interpret and summarize human molecular genetics scientific literature. Knowledge of laboratory operations is beneficial. Effective verbal and written communication abilities. PHYSICAL DEMANDS & WORK ENVIRONMENT: Duties are performed mainly in an office adjacent to a laboratory setting. Long duration of keyboard and screen use is expected. Duties may require working on weekends and/or after hours. Occasional travel is expected (less than 5% of the time).
Apex Life Sciences San Carlos, CA, USA
Jul 27, 2019
Full time
Associate Scientist/Scientist Job Summary We are currently seeking a highly motivated Associate Scientist/Scientist with strong hands-on experience to contribute to the discovery and characterization of therapeutic antibody candidates for cancer. The successful candidate will be responsible for designing and conducting preclinical studies to support various aspects of immuno-oncology therapeutic development from target validation to clinical development. The candidate will also participate in handling, preparing and storing blood samples from clinical trials, including maintaining a sample data base. Job Qualifications Ideal candidate will have MS in Immunology, Oncology, Cell Biology or related field plus 6 - 8+ years industry experience or PhD with 1+ year industry or post doc experience. Hands-on experience in immunology and oncology, preferably with isolation, manipulation and functional analysis of human immune cells subsets in whole blood and PBMC. Experienced and skilled in cell-based functional assay systems, including long-term cell culture, ELISA, multi-parameter flow cytometry, cell proliferation/apoptosis, ADCP, ADCC/CDC and activation of B cell, T cell, monocytes/macrophages and dendritic cells. Successful candidate will possess good interpersonal, verbal, and written communication skills; excellent organizational skills, attention to detail and precision with sterile techniques/procedures. Proficient in using data management programs such as MS Office and Graph Pad Prism. Strong motivation and desire to work in a fast-paced, cross functional team environment.