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Job Details

HEAD OF CMC

Company name
Arsenal Medical

Location
Waltham, MA, United States

Employment Type
Full-Time

Industry
Chemistry, Engineering

Posted on
Jun 18, 2021

Valid Through
Oct 01, 2021

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Profile

Description:

Arsenal Medical, Inc. is a Boston metro based, privately held, clinical stage, medical device start-up company committed to transforming medicine through the novel application of biomaterials to meet todays challenging unmet clinical needs. Our in situ forming biomaterials platform creates customized mechanical implants in the body to control the flow of bodily fluids, fill complex anatomical spaces, and/or apply physical pressure, as needed. These implants are formed by delivering liquids with tunable chemistries to specific locations in the body using minimally invasive delivery systems. Once at the target anatomy, the liquids react to form solid implants that take the shape of complex cavities in the body.

Arsenal Medical is seeking a Head of Chemistry, Manufacturing, and Controls (CMC), reporting to the CEO, who will be accountable for phase-appropriate CMC strategy and execution. Responsibilities include oversight of the chemistry and formulation development efforts, the manufacture and distribution of clinical and commercial product, management of contract manufacturing organizations (CMO’s), and the assurance of product service levels and quality. We are looking for a consummate, hands-on team player who is willing to roll up their sleeves and lead in a small, collaborative environment.

ESSENTIAL FUNCTIONS

Collaborate with project leaders to provide leadership and technical oversight on all CMC-related development efforts

Establish and oversee process optimization, formulation development, analytical testing, aseptic fill, and finished product manufacturing at external facilities

Oversee all aspects of CMC outsourcing including raw material and vendor selection, planning and reviewing technical content, leading technical and data driven decision making, negotiating plans, contracts, and supply agreements, holding CMOs accountable for performance, and internal and external auditing for both clinical and commercial product

Proactively manage risk mitigation strategies for critical path issues and program risks to ensure on-budget, timely delivery of program milestones and compliance with regulatory requirements

Author and review CMC sections of regulatory documents, study reports and other development related documents

Lead CMC operations in collaboration with existing Quality and Regulatory infrastructure

Attract, retain, and develop a small team of scientific professionals

Foster and embrace a culture of equity, diversity, caring, respect and continuous improvement in ourselves and our work

Requirements

B.S./M.S. with 12 years of CMC experience or Ph.D. with 8 years of CMC experience in Chemistry or Chemical Engineering or related discipline; title will be commensurate with experience

Experience in the combination medical device and/or life sciences industries

Technical depth and a broad understanding of chemical processes, analytical methods and formulation development

CMC project management or project leadership experience, including management of timelines and budget

Expertise overseeing the validation / transfer / maintenance of cGMP processes to ensure processes are appropriately scaled, qualified, and validated prior to commercial launch of our products

Proficient in the management of Contract Manufacturing Organizations, leading cGMP manufacturing activities for clinical and commercial product

Well versed in authoring and reviewing CMC sections of regulatory submissions, and interactions with global regulatory agencies

Excellent communication and organizational skills; comfortable navigating complexity and ambiguity in a fast-paced environment interacting with consultants, external vendors, and internal personnel

Experience working with polymer-based products is highly desired

A track record of achieving results in a virtual/outsourced model is key

Demonstrated ability to develop and grow internal talent

Able to travel up to 30%

Arsenal Medical, Inc. is committed to creating a diverse environment and is proud to be an equal opportunity employer. We will consider all qualified applicants for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected class.

Company info

Arsenal Medical

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