Associate Director Chemistry and ManufacturingApply for Associate Director Chemistry and Manufacturing . Opens in new window.
ProQR Therapeutics is a clinical-stage biotech company listed on NASDAQ with offices in Leiden, the Netherlands and Cambridge, Massachusetts, US. ProQR is focused on the development of game changing RNA therapies for severe genetic rare diseases. Our mission is to help patients by creating new medicines. A team of 160 enthusiastic ProQRians from all walks of life and more than 30 different nationalities is up to this challenge. We have the passion and commitment to make a difference in the lives of the patients we serve.
Our Chemical Manufacturing and Controls (CMC) department is currently looking for an Associate Director Chemistry and Manufacturing to join our team.
Leiden, NLProQR’s chemical manufacturing and controls (CMC) team has an immediate opening for an Associate Director. The individual will be responsible for leading and coordinating research and manufacturing operations for the production of (therapeutic) oligonucleotides at ProQR as well as managing activities at external contract research, development, and manufacturing organizations (CDMOs). Responsibilities will include process development of oligonucleotide Drug Substance (DS) manufacturing processes and production of (cGMP) drug substance batches.
ProQR is looking for an independent self-starter with experience in drug substance manufacturing under cGMP. This individual will be responsible for the preparation of technical reports and DS sections of CMC regulatory submissions.
Roles and Responsibilities
- Manage DS manufacturing activities at ProQR and at drug substance CDMOs. Interact with contract site management and staff (may include being on site)
- Manage the manufacture of drug substance for toxicology studies, clinical trials, and commercial supply at CDMOs, including review and approval of GMP documentation: 1) Process development and/or process transfer. 2) Change documentation. 3) Master and executed DS batch records. 4) Proactively manage risks and develops mitigation plans. Identify and communicate risks and issues that impact quality, compliance or project timelines.
- Prepare requests for proposals (RFPs) and technical packages for the procurement of GMP DS manufacturing campaigns
- Provide support and guidance to the analytical development and quality control (AD/QC) team in the development of appropriate analytical testing methods
- Proactively identify ways in which research and manufacturing objectives can be achieved on expedited timelines while advancing multiple risk mitigation strategies in parallel
- Work with QA and QC to prepare drug substance release and stability specifications and provide technical guidance for on-site audits
- Interpret and summarize complex data and serve as the primary author and lead writer of technical documents, development reports, and DS CMC sections for IND, IMPD and global marketing applications with
- minimal supervision.
We expect our Associate Director to have
- Ph.D. in organic chemistry or related discipline with 5+ years of experience, or Master’s with 8 years of experience, or a Bachelor’s degree with 10+ years pharmaceutical industry experience.
- Excellent scientific knowledge of process chemistry and preferably experience in oligonucleotide manufacturing (or solid phase synthesis in general)
- Prior manufacturing experience, including management of CDMOs, development of manufacturing processes and experience with good manufacturing practices for the preparation of drug substance for clinical studies and commercial supply
- Experience in drafting DS CMC sections (ICH CTD M3 format) of INDs, IMPDs, and/or marketing applications, and practiced in responding to inquiries from regulatory agency review
- Demonstrable knowledge of regulatory guidelines (FDA, EMA, ICH)
- Strong written and oral communication skills
- Team player with demonstrated ability to work well with other professionals within and across functions/teams
- Ability to multi-task and shift priorities rapidly to meet tight or changing deadlines
- Detail oriented and well organized.
Skills and competencies that are required for making the difference
- Flexible and resistant to change
- Hands-on mentality
- Autonomous and coachable
- Strong project planning and management skills
- Being able to prioritize multiple tasks
- Excellent communication skills
- Pro-active and pragmatic self-starter, with a result-oriented mindset
- Excellent knowledge of spoken and written English (and Dutch)
- A nice person :-)
ProQR as an employer
As an employer, we are a true believer of the value of a workforce in which people from diverse backgrounds are encouraged to develop themselves, personally and professionally. We believe that happy and energized people, working well together in an environment in which they thrive, will do phenomenal and awesome things. We are committed to ensure that no employee, candidate or job applicant receives less favorable treatment on the grounds of race, age, disability, pregnancy, religion, gender identity and expression, sexual orientation, marriage or civil partnership status. At ProQR we want to create an inclusive culture where everyone can be valued for who they are and in which individual differences and the contributions in all forms are recognized and valued.
We offer an exciting and innovative working environment in a very committed organization, with the following benefits:
- A competitive salary
- 8% holiday allowance
- 30 vacation days
- An annual performance bonus
- Stock options
- A premium-free pension plan
- A commuting allowance
- A subsidized staff restaurant
- Flexible working arrangements
- Unlimited (un)healthy snacks and drinks
- Employee events (boot camp, chair massage and other social events)
Do you think you can contribute in achieving our mission? If so, we’re looking forward to receiving your application by filling out our application form.
Please apply as soon as possible but before August 30th if you are interested in this position.
You can contact Femke Hekelaar via firstname.lastname@example.org if you have any questions. Please note that a screening is part of our selection procedure.