Gmp Quality Assurance Senior Manager

About Generate Biomedicines

Generate Biomedicines is a new kind of therapeutics company – existing at the intersection of machine learning, biological engineering, and medicine – pioneering Generative Biology™ to create breakthrough medicines where novel therapeutics are computationally generated, instead of being discovered. Generate has built a machine learning-powered biomedicines platform with the potential to generate new drugs across a wide range of biologic modalities. This platform represents a potentially fundamental shift in what is possible in the field of biotherapeutic development.

We pursue this audacious vision because we believe in the unique and revolutionary power of generative biology to radically transform the lives of billions, with an outsized opportunity for patients in need. We are seeking collaborative, relentless problem solvers that share our passion for impact to join us!

Generate was founded in 2018 by Flagship Pioneering and has received over $420 million in funding, providing the resources to rapidly scale the organization. The Company has offices in Somerville and Andover, Massachusetts with over 250 employees.

The Role:

The GMP Quality Assurance Senior Manager is responsible for all quality management and compliance of Generate's CMC and Manufacturing activities. This role interacts with vendors and Generate stakeholders to plan and manage activities and external partners to achieve evolving internal project and business goals

Here's how you will contribute:

• Other duties as needed
• Perform the disposition of both DS and DP.
• Participate in regulatory inspections and audits of Generate, as needed.
• Oversees vendor performance and delivery; identifies risks/deficiencies in current state vendor delivery.
• Perform Executed Batch Record review and approval for both drug substance (DS) and drug product (DP).
• Review Labeling vendor's master and executed packaging records.
• Drive vendors to seeks innovative ways to improve delivery and quality Develops and reports Key Performance Indicators to measure CMO and Labeler performance.
• Develop and reports Key Performance Indicators to measure CMO and Labeler performance and for contribution to Management Review.
• Develop internal DS and DP specifications.
• Develop and use Quality Agreements to manage vendor activities, outputs and records.
• Review and approves Generate specifications, Contract Manufacturing Organization (CMO) upstream and downstream reports, change controls, stability protocols, and related documentation.
• Review and approves Deviations, oversees CAPAs; trends issues.
• Oversee team members who act as vendor-specific GMP QA resources.
• Act as subject matter expert for internal SOPs, as needed.
• Create internal Certificates of Analysis for DS and DP release.
• Review IND Dossiers.

The Ideal Candidate will have:

• Analytical and problem-solving skills; experience in root cause analysis.
• MSc in Engineering, Microbiology, or related field with 7+ years of relevant experience in GMP industry regulation best practice, vendor oversight and audit experience or BSc degree in Engineering, Microbiology, or related field with 9+ years of relevant experience in GMP industry regulation best practice, vendor oversight and audit experience
• Knowledge of metrics definition and process measurement.
• Experience in inspection readiness and management.
• Oversight of CAPA timelines and effectiveness.
• Timeline management and experience using internal and external resources to achieve objectives.
• Experience in leading others.
• Experience interacting with and responding to US, EU, and other Health Authorities.
• Solid experience working within US and EU GMPs.

Who Will Love This Job:

• A root cause investigator, always looking for ways to improve and optimize.
• A detail-oriented, yet agile multitasker who thrives on timelines, completeness and on-time delivery.
• A collaborator, who knows how to enlist external partners to achieve project objectives.

Generate Biomedicines is committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status.

COVID Safety:

Generate Biomedicines enforces a mandatory vaccination policy for COVID-19. All employees must be fully vaccinated and have received a booster. The purpose of this policy is to safeguard the health of our employees, their families, and the community at large from infectious disease that may be reduced by vaccinations. The company will make exceptions to this policy if required by applicable law and will consider requests for an exemption from this policy due to a medical reason, or because of a sincerely held religious belief, or any other exemptions that may be recognized by applicable.

Recruitment & Staffing Agencies: Generate Biomedicines does not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to Generate Biomedicines or its employees is strictly prohibited unless contacted directly by Generate Biomedicines's internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Generate Biomedicines, and Generate will not owe any referral or other fees with respect thereto.

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