The Position The Associate Director, MS&T will lead teams of scientists, engineers, and documentation specialists to facilitate process transfer and scale-up activities from Process Development and Discovery to the Arrowhead internal manufacturing team. This team will also support new technology implementation, process troubleshooting, deviations/CAPAs, process validation, and process improvements as applicable.
Responsibilities
- Lead and coordinate the goals and activities of the process engineering, tech transfer, and process validation teams for Arrowhead internal oligo manufacturing operations
- Oversee GMP document generation functions for technology transfer and process validation activities
- Ensure all GMP documents within teams are prepared and maintained through compliant change control processes
- Manage teams of direct and indirect reports to ensure timely completion of high-quality work
- Collaborate with cross-functional teams to ensure seamless and timely process transfer
- Lead troubleshooting and assessments when unexpected manufacturing issues occur
- Provide regular status updates to stakeholders on project milestones
- Display consistently exceptional leadership qualities including but not limited to talent recruitment, leading with integrity, humility, empowerment, and flexibility
- Oversee the evaluation and optimization of manufacturing processes to improve efficiency, scalability, and compliance
- Remain current with latest advancements in oligonucleotide and related technologies, incorporating industry best practices into the technology transfer process
- Ensure compliance with all relevant regulatory agencies' requirements, such as FDA, EMA, and ICH guidelines
- Provide guidance and mentorship to team members, including development and career planning, knowledge sharing and learning opportunities, and professional growth
Requirements- PhD in Organic Chemistry or closely related field and 6+ years industrial experience, MS in Organic Chemistry or related field with 10+ years industrial experience, or BS in Chemistry or related field and 12+ years industrial experience in development, scale-up, and/or manufacturing of GMP drug substance
- Experience in scale-up of chemistry processes, preferably oligonucleotide synthesis, in a regulated environment.
- Experience with process validation on drug substance manufacturing processes
- Experience developing technology transfer procedures and systems
- Full understanding of analytical methods such as HPLC-MS, UV, NMR, etc.
- 12 years' experience in synthetic organic chemistry and/or technology transfer, within a GMP-regulated environment preferred
- Ability to work in a fast-paced environment and manage multiple priorities simultaneously
- Ability to work independently on complex assignments
- Strong safety background, with prior experience serving on facility safety committee a plus
- Successful in implementing ideas and influencing people in a team environment. Recognized for organized, effective, and professional communication skills. Strong ability to independently resolve interpersonal conflicts
- In-depth knowledge of GMP guidelines, ICH Q7, and relevant regulatory requirements for API manufacturing
- Strong project management skills, with a track record of successful technology transfer execution
- Excellent interpersonal skills to collaborate effectively with internal and external partners
- Exceptional written and verbal communication skills. Ability to interpret and communicate scientific results and to interact productively with scientists and engineers on the team
- Foster creative spirit to facilitate effective and collaborative problem solving
- While performing the duties of this job, the employee is regularly required to talk or hear. The employee frequently is required to sit and work with hands. The employee is occasionally required to stand; walk; reach above shoulder height; climb or balance; stoop, kneel, crouch, or crawl; and taste or smell. The employee must occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, and ability to adjust focus.
Wisconsin pay range
$165,000-$185,000 USD
Arrowhead provides competitive salaries and an excellent benefit package.
Candidates must have current, valid authorization to work in the country where this role is located.
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