Technical Project Manager; M​/F​/D) CMC; Chemistry, Manufacturing, and Controls

• Holistic Project Management:
  Managing interdisciplinary client and internal projects from initiation through successful implementation.
• Client Projects:
  Structuring and monitoring transfer and manufacturing processes with a focus on technical and regulatory project execution through to routine implementation.
• Internal Projects:
  Leading initiatives for continuous process and methodology optimization, as well as the introduction of new technologies.
• Interface Management & Milestone Tracking:
  Coordinating collaboration between the laboratory, quality management, and clinical sponsors, as well as monitoring project schedules, milestones, and resource capacities.
• Regulatory Focus (CMC):
  Contributing to the preparation, review, and compilation of CMC (Chemistry, Manufacturing, and Controls) documentation and other regulatory submissions.
• Project Management Development:
  Establishing and further developing project management for a newly created business unit as the first team member in this role.
• A successfully completed degree in the natural sciences (e.g., chemistry, biochemistry, pharmacy, or a comparable field).
• Professional experience in technical project management, ideally in the regulated environment of the pharmaceutical, biotech, or diagnostics industries.
• Regulatory expertise:
  In-depth knowledge of regulatory requirements as well as experience in preparing, reviewing, and evaluating regulatory documentation.
• Proficiency in using project management tools as well as agile and traditional project management methods.
• A high degree of initiative, strong organizational skills, and a pioneering spirit to proactively establish structures and processes as the first person in this role (hands-on mentality).
• Strong communication and coordination skills, as well as fluency in spoken and written German and English for the preparation of precise technical and regulatory documents.
• A pleasant working atmosphere in a dynamic team
• A challenging role with a high degree of personal responsibility
• JOBRAD
• Regular company events
• A family-friendly and expanding company

• Holistic Project Management:
  Managing interdisciplinary client and internal projects from initiation through successful implementation.
• Client Projects:
  Structuring and monitoring transfer and manufacturing processes with a focus on technical and regulatory project execution through to routine implementation.
• Internal Projects:
  Leading initiatives for continuous process and methodology optimization, as well as the introduction of new technologies.
• Interface Management & Milestone Tracking:
  Coordinating collaboration between the laboratory, quality management, and clinical sponsors, as well as monitoring project schedules, milestones, and resource capacities.
• Regulatory Focus (CMC):
  Contributing to the preparation, review, and compilation of CMC (Chemistry, Manufacturing, and Controls) documentation and other regulatory submissions.
• Project Management Development:
  Establishing and further developing project management for a newly created business unit as the first team member in this role.
• A successfully completed degree in the natural sciences (e.g., chemistry, biochemistry, pharmacy, or a comparable field).
• Professional experience in technical project management, ideally in the regulated environment of the pharmaceutical, biotech, or diagnostics industries.
• Regulatory expertise:
  In-depth knowledge of regulatory requirements as well as experience in preparing, reviewing, and evaluating regulatory documentation.
• Proficiency in using project management tools as well as agile and traditional project management methods.
• A high degree of initiative, strong organizational skills, and a pioneering spirit to proactively establish structures and processes as the first person in this role (hands-on mentality).
• Strong communication and coordination skills, as well as fluency in spoken and written German and English for the preparation of precise technical and regulatory documents.
• A permanent employment contract
• A pleasant working atmosphere in a dynamic team
• A challenging role with a high degree of personal responsibility
• Professional development opportunities
• JOBRAD
• Regular company events
• A family-friendly and expanding company

Intavis Peptide Services is a small but rapidly-growing biotech company that specializes in producing customized peptides for both laboratory and clinical research. At Intavis Peptide Services, we believe in the power of peptides to create new therapies for currently uncureable diseases.

Intavis develops and manufactures custom peptides for laboratory, discovery, and preclinical research. As part of our continued growth, we are expanding our production capabilities for Research and Advanced Grade products and are looking for new colleagues to join our team.

Founded in the late 1990s Intavis Peptide Services (IPS) has around 30 years of experience in peptide synthesis. As a part of the Intavis Instruments corporation we initially synthesized peptides to validate analytical…