Seuss +

CMC (Senior) Manager

Company
Seuss +
Location
Netherlands
Salary
Competitive
Posted
09 Apr 2021
Closes
08 May 2021
Ref
154748
Discipline
Manufacturing
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
The CMC Sr. Manager position is ideal for someone who thrives in a fluid and high-charged environment and rises to meet challenges. Reporting to the Head of CMC, the CMC Sr. Manager will oversee and manage all the pharmaceutical development and GMP production activities. You will work closely with contract manufacturing organizations (CMOs) and will be responsible to ensure that all applicable policies and procedures, including ICH requirements are met. In addition, you will identify, escalate, and solve any obstacles ensuring the clinical supply plan is executed and NDA/MAA submissions are on track.
As a successful CMC Sr. Manager/Director for our client, you’ll bring your breadth of experience, ranging from management and oversight of CMOs, Project Manager skills to ensure all DP production activities run smoothly and the documentation is accurate and comply with regulatory guidelines. You will also actively contribute to preparation for registration of the drug for marketing approval.

Main Roles & Responsibilities:
  • Oversee, manage and build relationships with CMOs and CRO counterparts in compliance with quality standards (SOPs, GMP etc.) including delivering feedback and holding others to timelines and deliverables while maintaining strong professional relationships
  • Coordination of tasks towards collection of required information and contribution to respective documents (e.g. risk analysis, briefing books, IND, IMPD, study plans and reports) in close collaboration with other relevant stakeholders
  • Responsible for ensuring that Drug Product plan aligns with overall development program and supports future NDA/MAA submission
  • Support the company’s regulatory submissions including preparation of Drug Product dossier in compliance with International Conference on Harmonization (ICH) guidance
  • Write and review of reports, submission documents, master and executed batch records, product specifications and all other documents related to the drug product development, production and test
  • Take on other pharmaceutical development projects to support the life cycle management of the pipeline
Qualifications & Experience:
  • Educated to B.Sc. or M.Sc. level in Pharmaceutics, Pharmaceutical Sciences, Chemical Engineering or related field.
  • 5+ years experience in Pharmaceutical Research & Development and product manufacturing in GMP environment; 2+ years as CMC manager
  • Track record of managing CMOs in line with contractual deliverables within timelines and budgets
  • Experience in Oral Solid Dosage manufacturing processes such as granulation (wet/dry), sustained release dosage forms, compression, coating, etc.
  • Experience in manufacturing process transfer and validation, including understanding and application of required standards and best practices and experience in leading quality/technical risk management activities
  • Experience with regulated industry Product Development and Regulatory requirements (knowledge of FDA requirements e.g. cGMP and marketing applications) and ICH guidance affecting drug product development (ICH Q1 to ICH Q14)
  • Working and theoretical knowledge of pharmaceutical ingredients, manufacturing, processing and testing equipment
  • Demonstrated experience with regulatory submissions in different markets with emphasis on late stage product development for registration and commercialization
Skills:
  • Fast-paced, high-capacity, versatile and energetic with demonstrated ability to manage multiple parallel assignments effectively with sense of urgency and reputation for meeting timelines and milestones
  • Well organized and detail oriented with a history of strong project management and analytical skills supporting the development and implementation of strategic plans
  • Prior history of effectively conducting remote oversight/supervision
  • Track record of being successful in ambiguous environments and adapting to a rapidly changing work environments
  • Works independently, often under pressure
  • Hands-on, flexible and team player
  • Excellent problem-solving and decision-making skills
  • Outstanding verbal and written communication skills

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