Technical Project & CMC Leader in Chemical Development API (897295-MGP)

Location
Canton of Basel-Stadt (CH)
Salary
negotiable
Posted
26 Feb 2021
Closes
28 Mar 2021
Hours
Full Time
Contract Type
Permanent
Experience Level
Management

Providing Flexible Resourcing Solutions

Founded in 1997 and headquartered in Basel, Switzerland, CTC is a specialist life-sciences recruitment organisation. We place specialist talent into contract and permanent positions in the pharmaceutical, biotech, medical devices and CRO industries.

An in-depth experience in life-sciences recruitment combined with an established and extensive local network means that CTC offers clients and candidates the “Gold standard” in recruitment services. With an expertise honed over many years at the cutting-edge of the life-sciences industry, we help companies find people and we help people find companies.

 

 

Technical Project & CMC Leader in Chemical Development API (897295-MGP)

 

Our client, an innovative and dynamic bio-pharmaceutical company headquartered in Switzerland, covering multiple therapeutic areas, committed into delivering products on the market over the next 5 years, is looking for a Technical Project & CMC Leader in Chemical Development API for a permanent position based in Basel area.

The ideal candidate should have 7 years of previous experience in the pharmaceutical industry and proven experience leading cross-functional teams.

Main Responsibilities:

As a Technical Project Leader:

  • Lead and manage development, analysis and production of drug substances;
  • Ensure sufficient and timely supplies for the market, based on input from the Planning & Procurement, for development projects, based on input from CMC, Project and/or Life Cycle management functions and on technical and scientific input from Chemical Process R&D within Chemical Development;
  • Identify need, requirements and opportunity for technology outsourcing;
  • Identify and select partner companies for the activities necessary for technical development and production;
  • Negotiate general, financial and technical agreements with the contractors supported by internal partners;
  • Monitor the partners with special emphasis on timelines, compliance, scientific quality, and cost-efficiency;
  • Track performance of suppliers (cost of goods, timelines, quality) in the relevant databases to support the supplier portfolio management;
  • Support QA to audit selected partners and to control cGMP status for clinical trial material and commercial product manufacturing;
  • Ensure compliance with regulatory guidelines and adapt to new initiatives;
  • Ensure seamless learning and know-how-curve from early Process Research to the CMO by maintaining a close-knit collaboration with Chemical Process R&D and the suppliers.

 

 

 

 

As a CMC Leader

  • Lead and manage all technical development and commercial manufacturing activities for both drug substance and drug product for assigned projects by developing and executing the overall CMC-project strategies considering all cross-functional aspects and by ensuring the implementation of the approved strategy within the Life Cycle Team, brand team and with involved third parties;
  • Supply risk management for all CMC activities: assess and mitigate supply risks with the functional experts within the CMC team;
  • Lead, manage and support the CMC-team. Set priorities, mentor and motivate CMC tea members;
  • Ensure optimal communication between CMC team members and between the CMC team and other departments.
  • Compile the Technical Development Plan including the CMC product strategy, and constructively challenge other functional plans. Ensure that overall project plan is considered in the CMC plan;
  • Assess and plan costs and resource needs for the assigned project. Prepare and monitor project plans and budgets and negotiate them with the relevant stakeholders;
  • Proactively communicate overall project strategy, key issues and any other critical topics in a timely manner to the appropriate management level;
  • Present and communicate the consolidated project status within the Life Cycle Team and other non-technical functions;
  • Represent Chemical Development in Due Diligence teams;
  • Support technical DRA in the preparation and timely availability of all relevant CMC source documents necessary for regulatory filings and health authority responses and provide strategic review of relevant CMC documents.

 

 

Qualifications and Experience:

  • Chemist or Chemical Engineer with PhD (preferred) and minimum 7 years of relevant experience in the pharmaceutical or chemical industry with at least 2 years of successful performance in the role of leading cross-functional teams in pharmaceutical development and/or commercial projects;
  • Excellent interpersonal and communication skills with the ability to adapt effectively to a rapidly changing environment;
  • Excellent leadership and open personality with proven team spirit to motivate and convince people and demonstrated the ability to influence stakeholders without line authority;
  • Availability and willingness to maintain high transparency and to live a sound success and failure culture to constantly improve overall performance;
  • Experience in setting development and regulatory strategies for products in development;
  • Ability to negotiate, plan, and coordinate technical development and manufacturing activities;
  • Scientific expertise in drug substance development and/or manufacturing;
  • Profound knowledge of GMP, quality control and pharmaceutical development and/or production processes;
  • Experience in QbD, DoE, process validation and registration is a plus;
  • Excellent English required (oral and written);
  • Excellent know-how of the pharmaceutical custom manufacturing market
  • Ability to deliver against challenging time and quality goals;
  • Relevant working/residency permit or Swiss/EU-Citizenship required.