Verve Therapeutics Jobs (NOW HIRING)

Organization Overview:

Verve Therapeutics Inc., a Wholly Owned Subsidiary of Eli Lilly and Company, Verve Therapeutics, a Lilly Research Labs subsidiary, is a clinical-stage genetic medicines company on a mission to solve cardiovascular disease. Founded by leaders in cardiovascular medicine and gene editing, Verve is developing one-time gene editing treatments aimed at turning chronic management into a single-course cure. Its lead programs target PCSK9 and ANGPTL3 to lower LDL-C, the root cause of cardiovascular disease.

Verve is seeking a Manager, Quality ControlExternalOperation,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 andcontract testing laboratoriesforLNP and other drugproductcomponentsfor earlydevelopment 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 theteamtomanageday-to-day Quality Controloperations at external partners. This individual will be working with theAssociate DirectorofQualityControl and will be supportingin-process, release, and stability testing bycoordinatingwith external partners.The position will be part oftheTechnical Operations team that aims to advance preclinical gene editing candidates into the clinic and works closely withQuality Assurance,External Manufacturing, Process Development, and internal/externalQualityControl.

• Manage cGMP testing (in-process, release, stability) at CDMOs and contract laboratories.

• Manage day-to-day Quality Control Operations atexternalpartners.

• Manage laboratory investigations, deviations, change controls,CAPAsand risk assessments.

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

• Manage material specifications for excipients, drugsubstancesand drug products.

• Manage the shipment of quality control samples from/to CDMOs and contract laboratories.

• Assistin coordination, oversight, and review of method validations at CDMOs and contract laboratories.

• Coordinatestabilitysample storage and testingperapproved protocols.

• Other duties as assigned

Basic Requirements:

• B.S. or M.S. degree in chemistry, biochemistry, biological sciences, pharmaceutical sciences, or related field.

• 5+yearsofrelevantexperience inthe pharmaceutical orbiotechnology industry

• 3+ years ofdemonstratedquality experience ina 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 experiencewith QC analytical techniques, such as HPLC, GC, CE, UV-VIS, ELISA, andcell-based potency assays.

• Ability to communicate across various cross-functional teams

• Experience authoring, reviewing and approving documents inElectronicDocument Management Systems(Veeva).

• Knowledge and understanding of ICH guidelines, FDA/EMA regulations, and cGMP documentation practices.

• Experiencewith external vendormanagement(client orclient facing function)

• Strong self-management and organizational skills, ability to prioritize, critical decision-makingskills, and problemsolving.

• Self-motivationandleadingthe way for ensuring a fair andequitablework 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:

• Thisis a hybrid position witha mandatory3days a weekon-siteat theFenway location in Boston, MA.

• Travel Percentage (%): 10%

• Overtime and shift work may berequiredto support GMP production at external CDMOs.