CMC Manager (incl. technical writer)

Job Purpose:

The position will be overseeing Chemistry, Manufacturing, and Controls (CMC) activities, ensuring the highest quality and compliance standards. Responsibilities will encompass a range of tasks, including technical writing, collaboration with manufacturing sites, and close coordination with Quality Assurance (QA) and Quality Control (QC) functions.

Main Tasks:

CMC Oversight:

• Manage all aspects of CMC activities for pharmaceutical and consumer health products, encompassing formulation development, process optimization, and analytical methods.

Technical Writing:

• Develop and maintain precise technical documentation, including CMC regulatory submissions (INDs, NDAs, MAA, Food supplement dossier, Cosmetics etc.).
• Create and update product specifications, master batch records, and standard operating procedures.

Manufacturing Site Liaison:

• Serve as the primary point of contact between the organization and manufacturing sites.
• Collaborate closely with manufacturing teams to ensure alignment with CMC strategies and objectives.

Quality Assurance/Quality Control Collaboration:

• Work collaboratively with QA and QC teams to implement and maintain quality standards throughout the manufacturing process.
• Participate in the development and execution of quality initiatives.

Regulatory Compliance:

• Stay abreast of regulatory changes and industry trends impacting CMC requirements.
• Ensure ongoing compliance with relevant regulations and guidelines.
• Prepare and review CMC sections of regulatory submissions to health authorities.

Process Optimization:

• Identify opportunities for process improvements and efficiency enhancements in collaboration with manufacturing teams.
• Implement changes to enhance the robustness and reliability of manufacturing processes.

Supply Chain Coordination:

• Collaborate with supply chain teams to manage inventory levels and ensure timely production and distribution.
• Implement strategies to enhance the reliability of the supply chain for pharmaceutical and consumer health products.

Requirements

• Bachelor's or advanced degree in a relevant scientific or engineering discipline.
• Proven experience in CMC management within the consumer health or related industries.
• Technical writing expertise with the ability to articulate complex CMC concepts in regulatory submissions.
• In-depth knowledge of formulation development, process optimization, and analytical methods in a consumer health context.
• Familiarity with regulatory requirements and guidelines related to consumer health products.
• Project management skills to oversee CMC processes and timelines.
• Effective communication skills to liaise with manufacturing, QA, QC, and regulatory teams.
• Collaborative mindset with the ability to work across functional areas.
• Knowledge of quality systems and practices in the pharmaceutical or consumer health sector.
• Adaptability to evolving industry standards and regulatory landscapes.

Benefits

We offer you..

• Growth Opportunities for strong performers
• Flexible working schedule
• Chance to work on cutting edge technology
• Fun working culture