Head of Analytical Development
Salary: Competitive
Location: Germany - Munich
I am currently working with a growing and innovative biotech company based in Munich who are advancing a broad and deep pipeline of novel medicines and growing out a brand new division.
This is an opportunity to support the R&D projects in a fast-paced environment whilst having the opportunity to influence and define the way that the portfolio and project management is being done. This person will have huge visibility into the organisation.
On Offer:
- Competitive basic salary and bonus scheme
- Car allowance / company car
- Flexible working environment
- Company Pension Scheme
- Healthcare Provision
Key Roles & Responsibilities:
- Provide world class technical leadership for the analytical development function
- Develop and implement work plans, provide appropriate resources, and incorporate expert knowledge, scientific and regulatory considerations, and business needs
- Ensure all methods developed comply with GMP guidelines and can be applied to commercial use for the industry.
- Transfer of analytical assays to CROs/CDMOs and provide support in troubleshooting
- You will lead the tech transfer of analytical assays from process development to GMP production.
- Develop, validate and support analytical methods and formulation, following relevant business, regulatory and consumer requirements.
- Provides scientific expertise to risk management and trouble-shooting investigations
- Acts as mentor/coach for more junior development scientist
The Candidate:
- Bachelor's Degree in Chemistry, Pharmacy, or related discipline
- Knowledge of cGMP requirements related to analytical chemistry within product development.
- German Fluency
- GMP industry experience 3 years' experience (minimum)
- Experienced in method development, method verification and validation (it is a plus if also method transfers are part of their experience)
- Has done also the documentation including the validation planning and reporting
Become part of a group that provides revolutionary change that provides patients with what they need.
Should you want more information, please do reach out:
Key Words: Analytical Development / Process Development / Formulation Development / Product Development / Biopharmaceuticals / Pharmaceuticals / Biotech / Development / Drug Development / Technology Transfer / DSP / USP / Director / CMC / GMP