About the position
The Sr. Manager, Specialized Chemical Development will support assigned process chemistry activities for drug substance (DS), DS intermediates and starting materials. The initial main focus for this position will be an oligonucleotide project, though work on small molecule or other modalities will be future possibilities. The scope of the role encompasses process research, scale-up activities, process definition, Process Performance Qualification (PPQ) and characterization/design-space mapping; it may include Person in Plant (PIP) oversight of manufacturing processes. Collaboration with Process Engineering will occur during routine manufacturing, technical transfer, PPQ and process improvement initiatives. Operating within a virtual (100% outsourced) business model, the employee will participate in CDMO selection and oversight, in conjunction with internal teams, and will be expected to foster the development of strong and enduring business partnerships. Strong technical writing skills are required, as this position will be involved in the development, review, and approval of Module 3 sections of CTD regulatory submissions, written responses to regulatory authorities, and other critical technical documents. This position will be located at the Waltham, Massachusetts office, though remote candidates will also be considered. Occasional domestic and international travel (up to 25%) will be required.
Responsibilities
- Support/manage process development activities and API scale up for an oligonucleotide project and other Deciphera assets.
- Critically analyze process and analytical data to identify and resolve key challenges during development.
- Participate in process chemistry teams or subteams engaged in external cGMP manufacturing of drug substance, DS intermediates and starting materials.
- Evaluate and implement innovative and practical synthetic routes to starting materials, intermediates, and drug substances.
- Work closely with internal Quality Assurance, Regulatory CMC, Supply Chain, Process Engineering, external manufacturing operations and other external and internal partners to ensure operational excellence with respect to timelines and attainment of technical, regulatory and quality objectives.
- Participate in the selection of drug substance CDMOs based upon core capabilities, capacity, and track record of regulatory compliance; participate in the evaluation of site technical, quality and business performance.
- Develop and maintain strong relationships with CDMO business partners.
- Review and author technical reports, controlled GMP documents (including master and executed batch records) and CMC content for Module 3 sections of regulatory dossiers.
- Continuously monitor vendor relationships; identify risks and establish mitigation plans and/or best practices to proactively address supply chain risks.
- May represent the Technical Operations organization in meetings with FDA, EMA and related regulatory authorities.
- May provide 'Person-in-plant' coverage during critical manufacturing events at CDMOs.
Requirements
- PhD or equivalent plus 3+ years of experience or Bachelors/Masters plus 8+ years of experience in pharmaceutical synthetic process research, development, and commercialization.
- Previous oligonucleotide experience strongly preferred.
- Familiarity with analytical techniques and manufacturing operations particular to oligonucleotides and other larger molecules (including preparative chromatography) is desirable.
- Track record of success in participating on teams for drug substance programs in a 100% outsourced environment.
- Experience with vendor/supplier management and excellent communication and cross-functional collaboration skills.
- Competency in developing, implementing and delivering project plans (milestones, timelines, resources, etc.) to successful endpoints.
- Ability to communicate effectively both in oral and written form, including preparation of internal reports and external communication with Deciphera partners.
- Strong decision-making skills and ability to influence internal and external stakeholders.
- Knowledge of the drug development process and ICH requirements for NDA and MAA registration.
- Experience in working with regulatory authorities.
- Experience authoring Module 3 CTD content.
- Ability to travel (up to 25%) to CDMO domestic and international sites.
- Fluency with standard computer software packages (MS Word, Excel, and PowerPoint, SciFinder, ChemDraw) and JMP (or similar statistical tools).
Benefits
- Competitive salary and annual bonus.
- Comprehensive benefits package including medical, dental, vision insurance, 401(k) retirement plan with company match, and more.
- Generous parental leave and family planning benefits.
- Outstanding culture and opportunities for personal and professional growth.
