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Director, Chemistry Manufacturing and Controls
Location:
Totowa, NJ
Description:
Job Description | Director, Chemistry Manufacturing and Controls Overview The Director of Chemistry Manufacturing and Controls (CMC) is responsible for leading the CMC strategy of the SOFIE IP assets' development program. In this role the Director will work closely with SOFIE's Chief Scientific Officer to set the strategy and direction for CMC efforts in support of SOFIE IP assets, including Fibroblast Activation Protein Inhibitor (FAPI), clinical development and post commercialization which includes optimization of Manufacturing and Quality Control methodologies, regulatory compliance and relationships with collaborators and critical third-party vendors. In addition, the Director will partner closely with SOFIE's technical transfer team in ensuring smooth transfer of SOFIE IP assets manufacturing across the SOFIE network and third-party partners. Essential Duties and Responsibilities Lead development of the CMC aspects of the SOFIE IP assets, serve as the central point of contact for SOFIE's vested partners, and supervise the development, manufacturing, and quality control strategy for the program. Work with a team of QC chemists, radiochemists, and production technicians to develop, optimize, and validate Production and Quality Control methods and procedures necessary for producing high quality and compliant doses. Draft, assess, review and approve Standard Operating Procedures for use in production and quality control. Work with SOFIE's QA, Regulatory, and EH&S teams to ensure SOFIE's standards are continuously reflected in the SOFIE IP assets development program and oversee generation of all regulatory documentation required for the life cycle of the asset, including Standard Operating Procedures (SOPs), Master Batch Records, and QC Records. Work closely with internal radiopharmacies and external CMOs/CROs for high quality and on time delivery of clinical supply and related critical material/development activities. Work with the appropriate teams to identify vendor selection and supply strategy. Initiate Change Control and perform risk assessments for the introduction of new materials, vendors, processes, procedures, and master records associated with SOFIE IP assets into the SOFIE QMS. Provide the CMC end-to-end strategy for scale up and commercialization of internal assets. Lead the CMC preparation of regulatory submissions such as BLAs, DMFs, INDs, and NDAs for internal assets. Interact closely with SOFIE's pharmaceutical partners and Sales/Marketing to develop realistic timelines for the introduction of internal assets and help with customer service and targeting efforts, including basic technical training and support to sales as needed. Manage resources to meet timelines through standard Project Management practices for a Contract Manufacturing Organization (e.g., project plan and GANTT chart generation, creating and adhering to strict budgets, reporting of resources, etc.). Work directly with the SOFIE technical transfer team, regional directors and key support staff to ensure smooth implementation of SOFIE IP assets production for clinical research and commercialization in each of the SOFIE and affiliate radiopharmacies. Work directly with the SOFIE Chief Scientific Officer to develop and support the CMC aspects of the overall SOFIE IP assets clinical development and commercialization strategy. Attend key industry and scientific forums to represent SOFIE as a subject matter expert on SOFIE IP assets' CMC. Compile and submit reports on all projects to management and customers as required. Continuously evaluate and optimize production and QC protocols for internal assets. Oversee any changes to production and/or QC protocols for internal assets. Oversee the procurement, maintenance and qualification of project-allocated manufacturing and analytical equipment. Report network manufacturing reliability, volume and implementation progress to SOFIE Leadership and key stakeholders at regular intervals. Collaborate with Corporate Quality and Operations groups to address logistic and supply chain challenges. Interface with product manufacturing sites to promote Good Manufacturing and Good Laboratory practices. Qualifications 10 years of relevant experience in drug development and supply chain. Biotech or Pharma industry experience, strongly preferred. Extensive experience with CMC, supply chain, and life cycle management. Familiarity with a GMP manufacturing environment and working with FDA and FDA cGMP regulations is required. Knowledge of molecular imaging techniques and pharmaceutical study design and execution is desired. Extensive experience filing and supporting regulatory filing, such as an IND/NDA and/or BLA. Advanced degree in organic, analytical or radiochemistry or related fields, or a B.S with comparative work experience required. Minimum 5 years of experience in the field of PET/SPECT radiopharmaceuticals (radiolabeled antibodies and peptides, radio-iodination, alpha and beta emitters chelation) required. Minimum 5 years of experience with HPLC methods development for radiopharmaceuticals required. Experience with other analytical techniques (e.g., radio-TLC, GC, endotoxin analysis, size exclusion chromatography, etc.) strongly preferred. Experience with radiochemistry synthesis, US FDA cGMP, radiation safety principles, isotope production, and analytical equipment troubleshooting and maintenance is preferred Strong skills as project manager/alliance manager. Expertise on cGMP, 21 CFR 212 or 211 required. Experience with aseptic filling preferred. Excellent communication skills, ability to be detail-oriented, and dependability required. Travel: up to 25% domestically or internationally. Ability to inspire confidence and create trust. Ability to work under pressure, plan personal workload effectively and delegate. Background in Nuclear Pharmacy, Positron Emission Tomography (PET) and the manufacture of PET radiopharmaceuticals, Radiation Safety/Regulatory Requirements for operations of a Radiopharmacy, and familiarity with Cyclotrons preferred but not required. PDN-9b726233-e88f-4022-a46b-1ffedc42e4cf
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Director, Chemistry Manufacturing and Controls is a Executive Director Job at Monster located in Totowa NJ. Find other listings like Director, Chemistry Manufacturing and Controls by searching Oodle for Executive Director Jobs.
Director, Chemistry Manufacturing and Controls is a Executive Director Job at Monster located in Totowa NJ. Find other listings like Director, Chemistry Manufacturing and Controls by searching Oodle for Executive Director Jobs.