How you will make an impact
* provide a full range of external quality control (qc) activities supporting halozyme’s enhanze programs across commercial, clinical, and development products and programs.
* oversee drug substance (ds) and drug product (dp) contract manufacturing organizations (cmos) producing and testing halozyme products, including supervision of staff.
in this role, you’ll have the opportunity to
* direct, lead, and develop a team of qc associates; mentor and provide growth opportunities.
* direct and manage technical external qc activities during gmp analyses (e.g., technical data review for in-process, release, and stability; support method transfers, qualifications, validations, and qa technical interactions).
* support cmos with qc-related investigations and analytical method issues.
* lead external qc activities, meet delivery dates, and lead technical areas across all programs while ensuring adherence to cgmp requirements at cmos.
* manage change controls for cmo analytical methods and laboratory impacting activities.
* support qc/analytical aspects of new product scale-up, process improvement, technology transfer, and process-validation.
* provide and manage required documentation: review/revision of procedures and specifications, annual product reviews, and support regulatory filing documents.
* coordinate specification document updates for control system review and shelf life/retest updates.
* communicate changes with partners; address partner regulatory information and program change requests.
* author and/or review qc and analytical-related regulatory sections.
* perform external audits/vendor qualifications (audit agendas and reports); support internal audits via audit readiness, responding to inquiries, and post-audit actions.
* initiate qc-related capas to maintain internal quality systems.
* maintain awareness of analytical and regulatory developments.
* develop/revise/implement/adhere to departmental policies and procedures affecting quality.
* contribute to the department budgeting process.
to succeed in this role, you’ll need
* bachelor’s degree in a scientific subject area or engineering; 10 years proven experience (combination of education and experience may be considered).
* strong background in analytical chemistry, microbiology, and biologics technologies; pharmaceutical qc experience.
* demonstrated experience leading reference standard and stability programs.
* expert writing and reviewing regulatory filings.
* detailed understanding of gmps, ich guidelines, and regulatory guidelines.
* ability to independently schedule, track, review, and report complex external qc activities.
* ability to work closely with internal departments, partners, and cmos (including senior management).
* effective problem-solving and negotiation skills.
preferred
* working knowledge and experience in qc assay development, qualification, and validation.
* experience with external parties (cmos, contract labs).
* knowledge of statistical software (e.g., jmp) and qms (e.g., mastercontrol).
in return, we offer you
* full and comprehensive benefit program, including an employee stock purchase program and 401(k) matching.
* opportunities to grow (learning/development, in-house programs, tuition reimbursement).
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