What are the responsibilities and job description for the Associate Director, Manufacturing Science and Technology position at Madrigal Pharmaceuticals Corporation?
Job Description
Job Description
About Madrigal :
Madrigal is a biopharmaceutical company pursuing novel therapeutics for non-alcoholic steatohepatitis (NASH), also known as metabolic dysfunction associated steatohepatitis (MASH). Our first therapy, Rezdiffra (resmetirom), was granted accelerated approval by the U.S. Food and Drug Administration (FDA) for the treatment of adults with NASH with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis) and is being studied in a Phase 3 trial for the treatment of NASH with compensated cirrhosis.
Role Overview :
Associate Director of Manufacturing Science and Technology (MSAT)
The Associate Director / Director of Manufacturing Science and Technology (MSAT) is responsible for leading the technical strategy and overseeing the implementation of scientific, technological, and operational processes in support of large-scale manufacturing operations. This role is integral in driving continuous improvement, ensuring production process optimization, and guiding technology transfers to enable efficient, high-quality manufacturing of pharmaceutical products (or applicable industry products).
The Associate Director of MSAT will work closely with cross-functional teams, including R&D, Quality Assurance, Regulatory, Engineering, and Operations, to ensure that all products are manufactured in compliance with regulatory standards while maintaining operational excellence. This is a Remote position.
Position Responsibilities :
- Works with management to plan and execute the MSAT department strategy for technology transfer from process development through to commercial manufacturing at external partners.
- Serve as the technical expert for Drug Substance and Drug Product manufacturing processes and provide guidance on problem-solving, process deviation resolution, and process optimization.
- Support external partner facility fit assessment, tech transfer activities, coordination of process start-up activities including Engineering Runs, GMP / clinical, PPQ and routine commercial runs, and resulting risk mitigation activities.
- Oversee process robustness monitoring and data analytics (modeling / trending) to identify opportunities for process optimization, cost reduction, and yield improvement.
- Travel will be required to support person-in-plant activities during production campaigns.
- Work closely internally with Quality Assurance and Regulatory teams to ensure that all manufacturing processes comply with GMP, FDA, and other applicable regulatory requirements.
- Collaborate with R&D on development projects and / or process versions to ensure manufacturability, scalability, and process consistency.
Qualifications and Skills Required :
Compensation :
Base salary is determined by several factors that include, but are not limited to, a successful candidate's qualifications, skills, education, experience, business needs, and market demands. The role may also be eligible for bonus, equity, and comprehensive benefits, which include flexible paid time off (PTO), medical, dental, vision, and life and disability insurance.
LI-remote
Madrigal is an Equal Opportunity Employer. All employment is decided on the basis of qualifications, merit, and business need. Applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex gender identity, sexual orientation, national origin, age, disability, protected veteran or disabled status, or other characteristic protected by applicable federal, state, or local law.
Unsolicited resumes from agencies should not be forwarded to Madrigal. Madrigal will not be responsible for any fees arising from the use of resumes through this source. Madrigal will only pay a fee to agencies if a formal agreement between Madrigal and the agency has been established.
Please be aware that we are currently receiving numerous reports of individuals misrepresenting themselves as Madrigal Pharmaceuticals’ Hiring Managers, seeking to engage with job candidates through fraudulent online advertisements or job posting sites. These unauthorized individuals are using Madrigal’s name and logo in an attempt to solicit up-front fees and obtain personal information from interested job candidates. Please know that Madrigal does not conduct interviews via text or in chat rooms; conduct interviews via Skype, RingCentral or solely via telephone; charge candidates an advance fee of any kind (e.g., fees for purchasing equipment); nor does it offer positions of employment without undergoing a thorough recruiting process. Interviews with Madrigal are conducted via the Zoom platform.
Please also note that any correspondence with regard to employment would come from an authorized madrigalpharma.com email address or from an email address from one of our trusted search firm partners. We are aware that incorrect / fraudulent email addresses, with Madrigal misspelled, have been utilized in these most recent fraud attempts. If you receive unsolicited employment offers from people claiming to work for Madrigal we recommend that you : do not respond to their questions; do not open any attachments; and do not click on any hyperlinks.
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