Manager / Sr. Manager, Drug Product Contract Manufacturing
Allakos Inc. is a dynamic clinical-stage biopharmaceutical company developing first-in-class antibody-based therapeutics to treat allergic and inflammatory diseases.
The company is seeking to recruit a Manager / Sr. Manager, Drug Product Contract Manufacturing. The ideal candidate will possess the following:
The Manager / Sr. Manager, DP Contract Manufacturing will plan, coordinate, and drive drug product CMC activities at the fill and finish contract manufacturers, including scale up for cGMP manufacturing. In addition to CMO oversight, this person will be responsible for troubleshooting, supporting investigations and cGMP manufacture to achieve timely delivery of cGMP therapeutics to support clinical trials and commercialization. This person will be part of a highly collaborative CMC group to support IND, IMPD, and BLA filings and serve as subject matter expert on cross-functional teams. This position reports to the Vice President, CMC.
- Manage CMO/CRO relationships, which includes planning, coordination and technical oversight of drug product activities to ensure timely delivery of cGMP products to support clinical trials. Serve as the primary contact to support drug product manufacture.
- Lead the process transfer of DP Mfg unit operations to commercial site(s). Support manufacturing campaigns with Person-in-Plant activities, deviation investigation and closure, and technical batch record review for batch release.
- Author and review batch records, campaign reports and other drug product documents.
- Provide technical recommendations for evaluating process data, troubleshooting and root cause analysis as well as strategic recommendations leading to improved yields, cost of goods and process robustness.
- Develop project risk strategy, identify gaps and mitigate risks. Ensure a validation plan is complete and supports successful regulatory submissions. Develop, review and approve process validation protocols, method transfer and advise on in-process testing.
- Provide vision for production methods, equipment, process validation requirements (IQ, OQ, PQ), release testing and supply chain management tools
- Be the drug product manufacturing subject matter expert on cross functional teams; present technical, quality and commercially-focused information to diverse audiences in a clear and consistent manner.
- Author and review drug product manufacturing sections of Regulatory submissions (i.e. IMPD/INDs/BLA), and responses to Regulatory agency questions.
- Conduct unbiased, timely, and economical comparisons of potential partners for competitive bidding processes and requests for proposals.
- Communicate effectively and transparently with functional heads within CMC, Quality, Regulatory, Clinical Operations and Commercial.
- BS in Chemical Engineering, Chemistry, Biochemistry or relevant field with a minimum of 10 years of relevant industry experience
- Extensive experience in clinical and commercial biologics manufacturing, preference given to candidates who have past experience managing contract manufacturers
- Experience supporting cGMP manufacturing through all phases of development (pre-IND to commercial)
- Experience with aseptic liquid filling of vials, aseptic preparation of pre-filled syringes. Strong background in the relevant unit operations including mixing, sterile filtration, sterilization, aseptic processing, component processing technologies, filling and visual inspection. Experience with device is a plus.
- Experience with cold-chain inventory management, including refrigerated and frozen capabilities
- In depth experience with FDA, EMA and industry, international regulatory and safety guidelines
- Prior experience with GMP fill-finish equipment, technology transfers, process validation and risk assessments is highly desired
- Development and manufacturing experience related to primary packaging components is highly desired
- Excellent communication, interpersonal skills, and people management skills through all levels of the organization
- Experience in early and late stage development as well as a small company environment is a plus
- Position may require occasional evening and/or weekend commitment
- Position may require occasional travel (up to 20%), domestic and international
The salary is competitive and commensurate with experience and qualifications.
Interested applicants please send resume to CMCcareers@allakos.com.
Allakos is an equal opportunity employer. Allakos will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.