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 ability to develop patient-oriented strategies that account for business needs and/or provide novel solutions to complex issues Lead and participate in quality investigations that require product quality impact assessments Demonstrate proficiency in oral and written communication of complex information to CMC leadership, peers and regulatory agencies Demonstrate proficiency in knowledge of cGMP and international regulatory expectations Support 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 timelines Develop and Implement Annual Product Review and other Product Quality processes Participate and provide oversight of CMO/CTL inspection readiness (e.g. PAI) Perform vendor audits both domestically and internally, as required Supervisory Responsibilities You Will Have None Requirements Here’s What You Will Bring to Anaptys: Education & Experience: Advanced degree in a biological science, chemistry, or related life science, Master’s required, PhD preferred 10 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 environment In-depth, working knowledge of cGMP compliance requirements for manufacturing and testing drug substance and drug product In-depth, working knowledge of the drug development process and ICH requirements related to CMC activities in support of IND and BLA registration Experience 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 simultaneously Ability 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 detail Demonstration 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 skills Project 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 yearend 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 move up to 10 pounds. Specific vision abilities required by this job include close vision and ability to adjust focus in order to read. Work Environment The work environment characteristics are representative of those an employee encounters while performing the essential functions of this job, typically in an open office environment. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually moderate. May be required to travel by plane or car. This position requires working with biological and/or chemical hazards. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status. Salary Description $156k-201k, 20% bonus,10% 401k, Options RSU