Sr. Director of Pharmaceutical Manufacturing Science & Technology

The Sr. Director of Pharmaceutical Manufacturing Science & Technology is a senior leadership role dedicated to supporting the supply of Active Pharmaceutical Ingredients (API), Drug Product (DP), and Finished Goods. This role involves working closely with Contract Manufacturing Organizations (CMOs) to drive technical solutions, manage risks, and promote manufacturing excellence. The ideal candidate will actively lead technical deviation investigations, leverage root cause analysis tools and methodologies, and collaborate with CMC, Regulatory Affairs, Quality Assurance (QA), and Supply Chain teams to ensure timely resolution of supply issues.

Position Responsibilities:

Technical Leadership:

• Provide technical guidance and support for the manufacturing of API, Drug Product, and Finished Goods
• Develop and implement technical solutions to address manufacturing challenges and improve processes
  
  

Collaboration with CMOs:

• Work closely with CMOs to ensure alignment and successful execution of manufacturing processes
• Drive technical discussions and solutions with CMOs to resolve issues and optimize production
  
  

Risk Management:

• Identify and assess risks associated with manufacturing processes and supply chains
• Develop and implement risk mitigation strategies to ensure continuous supply and product quality
  
  

Manufacturing Excellence:

• Promote a culture of manufacturing excellence by implementing best practices and continuous improvement initiatives
• Ensure compliance with regulatory standards and internal quality requirements
  
  

Cross-functional Collaboration:

• Actively collaborate with CMC, Regulatory Affairs, QA, and Supply Chain teams to ensure coordinated efforts and timely resolution of supply issues
• Serve as a technical liaison between internal teams and external manufacturing partners in support of ongoing supply, future manufacturing changes, and change control processes
• Support regulatory submissions and audits as needed
• Work across multiple technical areas, including formulation development, process development, scale-up, and commercialization
• Stay current with advancements in pharmaceutical manufacturing technologies and methodologies
• Actively lead technical deviation investigations and develop solutions
• Ensure root cause analysis is performed and corrective actions are implemented effectively
  
  

Qualifications and Skills Required:

Education:

• Bachelor’s degree in Chemical Engineering, Pharmaceutical Sciences, or a related field. Advanced degree (PhD or equivalent) preferred
  
  

Experience:

• Minimum of 15 years of experience in pharmaceutical manufacturing, with a strong background in API, Drug Product, and Finished Goods
• Proven experience in working with CMOs and driving technical solutions in a manufacturing environment
  
  

Skills:

• Strong technical expertise in pharmaceutical manufacturing processes and technologies
• Excellent problem-solving and risk management skills
• Effective leadership and project management skills
• Strong communication and interpersonal skills with the ability to collaborate across functions and with external partners
  
  

Attributes:

• Detail-oriented with a focus on maintaining high standards of quality and compliance
• Proactive and strategic thinker with a hands-on approach to solving technical challenges
• Ability to thrive in a fast-paced, dynamic environment and manage multiple priorities
  
  

This job description outlines the primary duties and qualifications for the Sr. Director of Pharmaceutical Manufacturing Science & Technology position, emphasizing the need for technical leadership, risk management, collaboration with CMOs, technical deviation investigations, and cross-functional teamwork to ensure manufacturing excellence and timely resolution of supply issues. This is a remote / telecommute position. Located within eastern time zone is preferred.

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.

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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