Quality Control Manager; External Operations

Position: Quality Control Manager (External Operations)
At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve.

This is hard, urgent, selfless work-but it's work worth doing. If you're driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

Organization Overview:

Verve Therapeutics Inc., a Wholly Owned Subsidiary of Eli Lilly and Company, is developing gene editing medicines for serious diseases. Regulatory affairs collaborates cross functionally within Verve and Lilly to build fit-for-purpose development plans and engage global health authorities. Regulatory affairs is seeking a dynamic leader with a growth mindset interested in building successful regulatory strategies. Verve is located in Boston, just down the road from Fenway Park.

Verve is seeking a Manager, Quality Control External Operation, who will report to the Associate Director, External Quality Control and be responsible for assisting with the continued implementation, and management of Quality Control activities at contract manufacturers and contract testing laboratories for LNP and other drug product components for early development stages. We are looking for a candidate with strong technical and compliance experience to support a pipeline of gene-editing products.

Responsibilities:

Verve's Quality Control is seeking a candidate for the team to manage 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 aims 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.

* Manage day-to-day Quality Control Operations at external partners.

* Manage laboratory investigations, deviations, change controls, CAPAs and risk assessments.

* Manage the review and approval of Quality Control data and CoA/CoTs.

* Manage material specifications for excipients, drug substances and drug products.

* Manage 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. or M.S. degree in chemistry, biochemistry, biological sciences, pharmaceutical sciences, or related field.

* 5+ years of relevant experience in the pharmaceutical or biotechnology industry

* 3+ years of demonstrated quality experience in a cGMP-regulated QC laboratory.

* 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 :

* Technical experience with QC analytical techniques, such as HPLC, GC, CE, UV-VIS, ELISA, and cell-based potency assays.

* Ability to communicate across various cross-functional teams

* 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.

* 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.

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