Director, External Manufacturing

at  Invicro

DIRECTOR, EXTERNAL MANUFACTURING

The Associate Director/Director, External Manufacturing will have responsibility for managing all chemical technical aspects of external manufacturing activities by 3rd party academic and commercial manufacturing facilities on behalf of Invicro.

QUALIFICATIONS

• Required BS, MS, or Ph.D degree in synthetic or analytical chemistry and/or equivalent work experience.
• Experience working within a PET/SPECT radiopharmaceutical clinical research environment.
• Strong background in the application of radiopharmaceuticals in support of drug development efforts
• Proficient at radiopharmaceutical process development with knowledge of relevant isotopes, automated synthesis platforms and analytical methods
• Able to develop, revise, and review SOPs, protocols, batch records, process development and technical reports.
• Excellent troubleshooting skills
• Experience working with Quality Management Systems including Non-Conformances, root cause investigations, CAPA, Risk & Change Management
• Excellent written and verbal communication skills with strong collaboration/ team building and organization skills to manage priorities and maintain timelines for multiple projects
• Good technical and regulatory understanding of GMP principles as related to radiopharmaceutical manufacturing.
  Headquartered in Boston, MA, Invicro was founded in 2008 with the mission of improving the role and function of imaging in translational drug discovery and development across all therapeutic areas. Today, Invicro’s multi-disciplinary team provides solutions to pharmaceutical and biotech companies across all stages of the drug development pipeline (Phase 0-IV), all imaging modalities and all therapeutic areas, including neurology, oncology, and systemic and rare diseases. Invicro’s quantitative biomarker services, advanced analytics and AI tools, and clinical operational services are backed by the company’s industry-leading software informatics platforms, VivoQuant® and iPACS®, as well as their pioneering IQ-Analytics Platform, which includes AmyloidIQ, TauIQ and DaTIQ.
  Invicro is an Equal Opportunity Employer. We maintain a drug-free work environment. All qualified applicants will receive consideration for employment without regard to actual or perceived race (and traits historically associated with race, including, but not limited to hair texture and protective hairstyles such as braids, locks, and twists), color, creed, religion, citizenship status, sex or gender (including pregnancy, childbirth and related medical conditions), parental status, sexual orientation, gender identity, gender expression (including transgender status), national origin, ancestry, age, marital status or protected veteran status and will not be discriminated against on the basis of physical or mental disability, protected medical condition as defined by applicable state or local law, genetic information, political affiliation or any other characteristic protected by applicable federal, state, or local laws and ordinances.
  Invicro does not accept unsolicited resumes from individual recruiters, third party recruiting agencies, outside recruiters or firms without an executed contract in place. We are not responsible for any fees related to resumes that are unsolicited or are received by Invicro. Such resumes will be deemed the sole property of Invicro and will be processed accordingly.

• Identify potential partner sites based on project needs and process complexity
• Partner with third party quality oversight department to ensure partner sites and critical vendors are qualified for GMP activities in a timely manner
• Ownership for product specification in line with project needs
• Ownership for preparation and revision of CMC documents for regulatory submission of external manufacturing projects
• Serve as primary technical interface between project needs, internal process specialists and 3rd party manufacturing sites
• Oversee technology transfer projects (implementation of manufacturing and testing procedures) related to the manufacturing and testing of current and new PET and SPECT radiopharmaceuticals
• Oversee outsourcing of precursor and reference standards according to business and project needs
• Oversee process and analytical chemistry optimization or modification based on identified project needs
• Work closely with the Invicro appointed project manager(s) to ensure wider project deliverables are met
• Support troubleshooting of manufacturing and QC processes and systems at external sites
• Support preparation and review of SOP and GMP relevant documentation at external sites
• Provide technical review of validation documents and batch records generated by external sites
• Support Quality Team in ensuring compliance with GMP at external sites
• Support Regulatory Team with national and international submissions
• Identify and escalate risks and issues likely to impact project deliverable timelines to relevant internal and external stakeholders to senior leadership
• Document tech transfer progress and author technical reports and other manufacturing documents necessary for investigations, continuous process improvements and other documents as may be required
• And other duties as assigned.