Quality Control Manager (External Operation)

Responsibilities

Verve's Quality Control is seeking a candidate for the team to lead day-to-day Quality Control operations at external partners. This individual will be working with the Associate Director of Quality Control and will be supporting in-process, release, and stability testing by coordinating with external partners. The position will be part of the Technical Operations team that strives to advance preclinical gene editing candidates into the clinic and works closely with Quality Assurance, External Manufacturing, Process Development, and internal/external Quality Control.

• Manage cGMP testing (in-process, release, stability) at CDMOs and contract laboratories.
• Run day-to-day Quality Control Operations at external partners.
• Manage laboratory investigations, deviations, change controls, CAPAs and risk assessments.
• Lead the review and approval of Quality Control data and CoA/CoTs.
• Manage material specifications for excipients, drug substances and drug products.
• Handle the shipment of quality control samples from/to CDMOs and contract laboratories.
• Assist in coordination, oversight, and review of method validations at CDMOs and contract laboratories.
• Coordinate stability sample storage and testing per approved protocols.
• Other duties as assigned

Basic Requirements

• B.S. degree in chemistry, biochemistry, biological sciences, pharmaceutical sciences, or related field with 5+ years of relevant experience in the pharmaceutical or biotechnology industry

OR

• MS degree in chemistry, biochemistry, biological sciences, pharmaceutical sciences, or related field with 3+ years of relevant experience in the pharmaceutical or biotechnology industry
• 3+ years of demonstrated quality experience in a cGMP-regulated QC laboratory.
• Technical experience with QC analytical techniques, such as HPLC, GC, CE, UV-VIS, ELISA, and cell-based potency assays.
• Experience authoring, reviewing and approving documents in Electronic Document Management Systems (Veeva).
• Knowledge and understanding of ICH guidelines, FDA/EMA regulations, and cGMP documentation practices.
• Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1

Additional Skills/Preferences

• Ability to communicate across various cross-functional teams
• Experience with external vendor management (client or client facing function)
• Strong self-management and organizational skills, ability to prioritize, critical decision-making skills, and problem solving.
• Self-motivation and leading the way for ensuring a fair and equitable work environment
• Thorough attention to detail, with the ability to critically analyze ideas, data, and reports.
• Strong oral and written communication and interpersonal skills

Additional Information

• This is a hybrid position with a mandatory 3 days a week on-site at the Fenway location in Boston, MA.
• Travel Percentage: 10%
• Overtime and shift work may be required to support GMP production at external CDMOs.

Additional information

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women's Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $72,000 - $169,400

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance).

In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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