Senior CMC Project Manager – Biotech – Netherlands
- Employer
- Planet Pharma Staffing Limited
- Location
- Leiden, Netherlands
- Salary
- Competitive
- Start date
- 9 Jul 2021
- Closing date
- 8 Aug 2021
View more
- Discipline
- Manufacturing, Regulatory Affairs, CMC
- Hours
- Full Time
- Contract Type
- Permanent
- Experience Level
- Experienced (non-manager)
Job Details
We are currently recruiting for a Project Manager for CMC at a Netherlands based Biotech. This is a fantastic opportunity for an experienced project manager to join a growing international biotechnology company and further develop experience within Chemistry, Manufacturing & Control as a key part of the Non-Clinical Safety Team.
Responsibilities
- Management of external CMC projects of the company’s product candidates
- Review of plans, reports and other critical documents of outsourced CMC activities
- Ensuring that the process development and manufacturing activities for the company are conducted in line with good scientific principles and within regulatory guidelines, according to GMP, GLP and GDP where applicable
- Management of the availability of clinical supplies, including the labelling, packaging, and expiry date setting
- Selection and performance monitoring of contractors for CMC activities
- Assistance with preparation and review of regulatory filing
- Monitoring and updating the project plans and timelines relating to the outcome of developmental projects
- Proactive reporting of the status and planning of CMC activities
Requirements
- Antibody development experience ideal (but not necessarily required, large molecule experience also suitable for example). Drug substances and/or drug product manufacturing is also advantageous
- Drug product, analytical development, upstream or downstream experience
- Clinical Production (GMP) experience
- Good understanding of quality systems such as GMP, GLP and/or GDP
Following your application Simon Trebilcock, a specialist Scientific Recruiter with over 7 years’ experience recruiting in the field will discuss the opportunity with you in detail. He will be more than happy to answer any questions relating to the pharmaceutical industry and the potential for your career growth. The conversation can also progress further to discussing other opportunities which are also available right now or will be imminently becoming available.
This position has been highly popular, and it is likely that it will close prematurely. We recommend applying as soon as possible to avoid disappointment. If you have any questions please reach out to Simon directly at strebilcock@planet-pharma.co.uk and/or 0203 928 6632.
About Planet Pharma
Planet Pharma is an American parented Employment Business/Agency that provides global staffing services with its headquarters in Chicago and our EMEA regional office located in Central London. We have invested significantly in creating a robust international platform that enables us to work compliantly in 30+ countries with a current network of 2500+ active contractors globally as well as a very strong permanent / direct hire recruitment offering.
Our specialist knowledge and close relationships with our clients and the wider industry really makes us unique in our field. Just recently we were recognised by FORBES as the 17th best professional staffing firm and have won multiple awards from industry accredited bodies for our commitment to excellence and service delivery. We have extensive functional expertise including Regulatory Affairs, Pharmacovigilance, QA, QC, Submissions experts, Clinical development, Quality, Biostatistics, and Medical Affairs / Writing.
We are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation, or age.
www.planet-pharma.com
Company
Planet Pharma was founded by a dedicated team of professionals with extensive experience supporting the pharmaceutical, biotechnology, and device industries.
Our goal is to create an organization that strengthens the employer-employee dynamic by connecting clients with talent. This results in making staffing more personal and creating enduring, valuable relationships. We value communication with our clients and make it our priority to have the hiring process be as fast and successful as possible.
We leverage cutting-edge technology and flexible service delivery models that provide efficient, personalized solutions for your business.
Our global headquarters is in Northbrook, IL and branch offices are based across the United States and Europe.
- Website
- http://www.planet-pharma.co.uk/
- Telephone
- +44 203 868 1000
- Location
-
10 Greycoat Place
London
England
SW1P 1SB
United Kingdom
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