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Process Chemist for API Contract Manufacturing (m/f)
Global Pharmaceutical Company with a European hub in Basel
Challenging opportunity working on projects with CMOs across Europe
About Our Client
Our client is global specialised pharmaceutical company that belongs to one of top 20 global pharma corporations.
The position belongs to the team that is specialized in providing technical support and oversight to the network of active pharmaceutical ingredient (API) contract manufacturers and API generic suppliers worldwide. The API team acts within a global External Manufacturing (EM) organization .
In addition the API team partners with other departments like R&D, Supply Chain, Quality or finished product manufacturers throughout the commercialization and launch of new products, covering a wide variety of API technology platforms. The API team's role in product commercialization, focused on ensuring a robust manufacturing process capable of supply market demand at competitive cost, offers a wide variety of project assignments and work experiences.
The core responsibilities in the manufacturing part of the job would be:
- Provide technical support to API, intermediate and starting materials contract manufacturers/suppliers
- Develop and maintain manufacturing instructions
- Manage changes of manufacturing instructions
- Support on the scale-up process
- Work with cross-functional groups to troubleshoot issues arising at contract manufacturing sites, including but not limited to deviations
- Perform regular on site visits at contract manufacturers
- Review process and product data for adverse trends; assess and understand process capability
- Liaise with contract manufacturers in the event of site transfers
- Serve as primary technical resource for manufacturing process
- Identify, evaluate, and implement process improvements with a focus on capability, compliance, and cost
- Conduct / support process validation
- Review and/or approve Annual Product Quality Reviews (APQR)
The main activities supporting new product commercialization would be:
- Participate in the evaluation of new business opportunities thru due diligence, product reviews, and cost modeling
- Support the commercialization of new products by partnering with R&D colleagues in the later phase of the development process
- Ensure manufacturing concerns are addressed at phase-appropriate points of development; effectively apply principles of Quality by Design (QbD) as applicable
- Facilitate the Manufacturability Review process
- Support the identification, selection, and approval of contract manufacturers
- Lead technical transfer, process implementation, and validation activities
Support launches in secondary markets, ensuring regulatory commitments are aligned
The Successful Applicant
We are targeting candidates with a BSc/MSc degree in Organic Chemistry or a similar education with at least 5 to 10 years of experience in a similar position in the pharmaceutical manufacturing sector.
We are looking for a specialist that has a strong understanding of GMP/cGMP requirements for drug substance and drug product manufacturing.
In addition there is a preference for a candidate with experience in multiple technology platforms that usually applies for the manufacture of small synthetic molecules and natural compounds (large molecules).
Knowhow or experience in new product introduction from the industrial point of view would be a strong plus as well.
Expertise or work experience with tools like Trackwise would be nice to have.
In terms of soft skills we expect the following ones:
- Strong project management skills
- Strong problem solving skills, including strategic and creative thinking
- Strong interpersonal skills
- Clear, concise communication skills (both written and verbal)
- Cross-functional networking skills: demonstrated ability to influence others and to work with remote partners
- Strong analytical skills
- Ability to handle multiple priorities and deal with ambiguity
- Demonstrated ability to achieve results with people
The work environment is English speaking and a fluent business English level is an absolute must for this position. Additional languages would be a plus.
The job will have a 10% to 25% travelling component, the hired candidate needs to be able to travel mainly to contract manufacturing suppliers across Europe plus some occasional travel to USA, China and India.
What's on Offer
Competitive salary and benefits.