Director, Product Quality

Job Type: Full-time
What you should know about Anaptys: Anaptys is an immunology-focused, clinical-stage biotechnology company with a 19-year track record of discovering life-changing therapeutic antibodies.
Over that time, we have worked to create a work environment where every role has meaning, every team member is respected, and every day is a chance to make a difference for people living with autoimmune and inflammatory diseases.
Our portfolio today includes two checkpoint agonists: ANB032, our BTLA agonist, in a Phase 2b trial for the treatment of atopic dermatitis, and rosnilimab, our PD-1 agonist, in a Phase 2b trial for the treatment of rheumatoid arthritis and in a Phase 2 trial for the treatment of ulcerative colitis.
We also have other immune cell modulator candidates in our portfolio, including ANB033, an anti-CD122 antagonist antibody, entering a Phase 1 trial, and ANB101, a BDCA2 modulator antibody, in preclinical development.
Our success is rooted in the diversity of our teams' experience, knowledge, and background.
We're doers, thinkers, and collaborators who embrace and live by our values: accountability, transparency, and humility.
Here's What You Will Do: Essential Functions You Will Be Responsible For: Provide effective, cross-functional product quality leadership, and support CMC deliverables for AnaptysBio programs, including actions required for the CMC team, APR, specification, comparability, and stability programs; site and method transfers; product quality impact statements for NCs; and PQ owned regulatory filing sections (specifications, justification of specs, stability, etc.
)Support science and risk-based evaluation of complex process and product quality data, including the ability to develop patient-oriented strategies that account for business needs and/or provide novel solutions to complex issuesLead and participate in quality investigations that require product quality impact assessmentsDemonstrate proficiency in oral and written communication of complex information to CMC leadership, peers, and regulatory agenciesDemonstrate proficiency in knowledge of cGMP and international regulatory expectationsSupport the product quality oversight of manufacture and analysis of Drug Substance and Drug Products and packaging and labeling of clinical and commercial supplies at Contract Manufacturing Organizations (CMOs)Review and approve validation protocols, raw data, and reports (Analytical Method, Process, Cleaning, etc.
)Perform data integrity and compliance assessments including review against source documentation for regulatory submissions (e.g., Module 3)Support the internal Change Control, Deviation, and Quality Investigation systems.Maintain effective communication with CDMOs and deliver Quality objectives in accordance with project timelinesDevelop and Implement Annual Product Review and other Product Quality processesParticipate and provide oversight of CMO/CTL inspection readiness (e.g.
PAI)Perform vendor audits both domestically and internally, as requiredSupervisory Responsibilities You Will Have: NoneHere's What You Will Bring to Anaptys: Education & Experience: Advanced degree in a biological science, chemistry, or related life science, Master's required, PhD preferred10+ years of relevant experience in biologics development including late-stage development (Ph.D. preferred)Other Compliance or Regulatory certifications (e.g., RAC, ASQ) a plus.Increasing responsibility in a quality, analytical development, process development, regulatory, or manufacturing environmentIn-depth, working knowledge of cGMP compliance requirements for manufacturing and testing drug substance and drug productIn-depth, working knowledge of the drug development process and ICH requirements related to CMC activities in support of IND and BLA registrationExperience in CDMO management and cross-functional collaboration skills.Capable of working successfully in a team/matrix environment and independently, as required.Knowledge and Competencies: Ability to meet deadlines, demonstrate efficient and effective use of time, and handle multiple assignments simultaneouslyAbility to convey both written and verbal information effectively and efficiently.Can follow procedures and perform assignments with a high degree of accuracy and careful attention to detailDemonstration of strong communication skills, leadership skills, and ability to effectively influence others.Ability to work independently to execute strategic plans.Strong understanding of GMP/GLP regulations.Significant work experience in a virtual (100% outsourced) biopharmaceutical development business model is preferred.Open and transparent communication skills (verbal and written)Solid organizational and time management skillsProject management skills and computer proficiency.Experience auditing suppliers, CMOs, and CTLs.Experience in planning for and involvement in Regulatory inspections (e.g.
PAIs)Ability and willingness to travel 20% of the time (internationally and domestically).What's Included in Your Compensation and Benefits Package: Our generous benefits package is industry leading.
Beyond base salary and a target bonus, we offer stock options, RSUs, and a 10% 401k match to help you secure your financial future.
Our robust time off policy provides employees a unique holiday schedule that incorporates long weekends throughout the year, in addition to the year-end company closing and additional vacation time.
Of course, we round out our benefits with company-sponsored dental, vision, and life insurance plans.
Our medical plans are benchmarked and are considered extremely competitive.
What Else You Should Know: Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to sit and talk or hear.
The employee frequently is required to use hands to finger, handle, or feel.
The employee is occasionally required to stand, walk, and reach with hands and arms.
The employee must occasionally lift and/or

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