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Director/Senior Director CMC

Company: Crelate, Inc.
Location: Cambridge
Posted on: April 8, 2021

Job Description:

It is an exciting time to join our company, with several late-stage programs, NDA submissions in the near term, and numerous pipeline programs in various indications. The Director/Senior Director CMC will be the senior leader for all CMC deliverables, including clinical supplies, tech transfer, scale-up, NDA readiness for both drug substance and drug product, and the CMC regulatory filings and negotiations. The individual will also be accountable for the selection of and management of CMOs, setting CMC strategy for the company, and representing all aspects of CMC on cross-functional project teams. The ideal candidate will have prior experience leading small molecule CMC activities from the lead optimization phase to commercialization. RESPONSIBILITIES -- Overall responsibility for all drug substance, product process, analytical development, and manufacturing activities from clinical development through commercialization -- Identification, selection, and management of Contract Development & Manufacturing Organizations (CDMOs) for process optimization, cGMP manufacture of Drug Substance (DS) and Drug Product (DP) in support of ongoing clinical programs and subsequent commercial supply in compliance with cGMP, ICH, and FDA regulations -- CMC representative on the project team. Proactively identifying knowledge gaps and risks and working with the team to develop mitigation plans -- CMC representative for the tech transfer in-house of a biologic from a large pharma partner -- Own the technical content of the CMC sections of INDs, CTAs, NDA's, and other regulatory submissions; represent the company as the CMC expert before regulatory authorities -- Monitor departmental compliance with required training and adherence to all corporate and departmental SOPs, GMP/ICH guidelines, and QC/QA procedures QUALIFICATIONS -- Ph.D. or MS with 12+ years of experience in product development and manufacturing; Advanced degree in Chemistry, Pharmaceutical Chemistry, Pharmaceutical Science, Chemical Engineering, or related scientific discipline preferred. Experience in small molecules is required -- Experience with process and formulation development and establishment of supporting analytical methods for both DS and DP characterization and release. -- Experience with late-stage clinical development, including process validation and pre-approval regulatory inspections (PAI) -- Experienced in cGMP manufacturing and a proven track record leveraging and managing US and International CRO/CMOs for the manufacture of cGMP DS and DP -- A proven track record guiding the CMC sections/quality modules for regulatory submissions and knowledge of current regulations. An ability to identify and resolve critical issues -- Strong interpersonal skills are required, and the successful candidate will work in a cross-functional matrix environment and will be expected to influence the direction of the late-stage clinical programs -- Excellent written and verbal communication skills with an ability to convey CMC strategy and results to a varied audience -- Meticulous, self-motivated, decisive, and independent with a willingness to work in a fast-paced environment -- A thorough understanding of ICH, GMP, and relevant regulatory requirement -- Ability to travel 20% Leadership and Communication: Excellent written and verbal communicator and can facilitate/articulate recommendations and critical decision points to senior management; demonstrated experience reducing complex subjects to key points; ability to develop a strong network across company. Relationship Management: Ability to develop new business relationships and to nurture partnerships with internal and external stakeholders. Ability to provide strong cross-functional team leadership to maintain alignment and to set and meet collaborative operational goals.

Keywords: Crelate, Inc., Cambridge , Director/Senior Director CMC, Executive , Cambridge, Massachusetts

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