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- Tasks: Lead a team to develop scalable production processes for nucleic acids and drive external manufacturing.
- Company: Stylus Medicine is pioneering in the field of genetic medicines, focusing on innovative drug development.
- Benefits: Enjoy a full-time role with opportunities for collaboration and professional growth in a dynamic environment.
- Why this job: Join a cutting-edge team making a real impact in genetic medicine and work on exciting projects.
- Qualifications: PhD or MS in Chemical/Biological Engineering with extensive industry experience in process development.
- Other info: This role offers a chance to mentor junior researchers and collaborate across multidisciplinary teams.
The predicted salary is between 72000 - 108000 £ per year.
Principal Scientist, Process Development Principal Scientist, Process Development Get AI-powered advice on this job and more exclusive features. Stylus Medicine is seeking an intellectually curious and collaborative Principal Scientist, who will lead the process development activities for nucleic acids and drive external manufacturing. The ideal candidate will have strong experience in developing scalable production processes for nucleic acids including DNA and/or mRNA. Within the role, the candidate will be responsible for process definition, development, characterization, scale-up and tech transfer from bench scale to Phase I GMP manufacture of the drug substance. This position will interface with cross-functional teams to progress new in vivo genetic medicines through the pipeline. Key Responsibilities & Accountabilities: Lead a high performing team to develop scalable production processes for nucleic acids Leverage expertise in fermentation, high throughput screening, chromatography and filtration principles to advance novel in vivo genetic medicines across different stages of drug development Screen, optimize and scale up production processes using design of experiments (DoE) principles Work in close collaboration with the discovery team, formulation team and in vivo pharmacology team to support in vitro and in vivo experiments assessing safety and efficacy of the products produced Spearhead internal innovation to improve nucleic acid quality and production yields that support commercially viable GMP scale up Interface closely, as the primary point of contact, with CDMO organizations to execute and support technology transfers, manufacture and release of the drug substance Discuss development program risks and/or experimental data with cross-functional teams to evaluate process performance, adjust development plans and ensure integrated program timeline success Plan, organize, coordinate and lead activities to ensure progress of internal and external projects and their compliance to phase appropriate GLP and cGMP standards Author study plans and reports and present findings at cross-functional team meetings Qualifications & Skills: PhD in Chemical or Biological Engineering, with 6 years of proven industry experience in leading process development, analytical characterization and scale up; or MS in Chemical or Biological Engineering, with 12 years of industry experience Strong experience in process sciences, aseptic technologies, quality controls and technology transfer to CROs/CDMOs Experience in supporting GMP manufacture and release of drug substance Experience with IND filing and answering regulatory questions is a plus Attention to detail and accuracy in developing and reviewing SOPs, batch records and technology transfer documents Demonstrated ability to collaborate with multidisciplinary teams for successful outcomes Demonstrated ability to coach and mentor junior researchers Independently motivated and good problem-solving ability Ability to work collaboratively across teams to meet project deliverables and timelines Strong communication, decision-making and organizational skills Applicants can submit their resumes to careers@stylusmedicine.com Seniority level Seniority level Mid-Senior level Employment type Employment type Full-time Job function Job function Research, Analyst, and Information Technology Referrals increase your chances of interviewing at Stylus Medicine by 2x Get notified about new Process Development Scientist jobs in Greater Boston . 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Principal Scientist, Process Development employer: Stylus Medicine
Contact Detail:
Stylus Medicine Recruiting Team
careers@stylusmedicine.com
StudySmarter Expert Advice 🤫
We think this is how you could land Principal Scientist, Process Development
✨Tip Number 1
Network with professionals in the nucleic acids field. Attend industry conferences or webinars where you can meet potential colleagues and learn about the latest trends in process development. This can help you gain insights into what companies like Stylus Medicine are looking for.
✨Tip Number 2
Familiarise yourself with the latest advancements in GMP manufacturing and technology transfer processes. Being well-versed in these areas will not only boost your confidence but also demonstrate your commitment to staying current in the field.
✨Tip Number 3
Prepare to discuss specific examples of your past work in developing scalable production processes. Highlight any successful projects where you led a team or collaborated with cross-functional teams, as this aligns closely with the responsibilities of the Principal Scientist role.
✨Tip Number 4
Showcase your problem-solving skills by thinking of potential challenges that may arise in nucleic acid production and how you would address them. This proactive approach can set you apart during interviews and discussions with hiring managers.
We think you need these skills to ace Principal Scientist, Process Development
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in process development, particularly with nucleic acids like DNA and mRNA. Emphasise your leadership roles and any specific projects that align with the responsibilities outlined in the job description.
Craft a Compelling Cover Letter: In your cover letter, express your passion for genetic medicine and detail how your background in fermentation, chromatography, and tech transfer makes you an ideal fit for the role. Use specific examples to demonstrate your problem-solving skills and ability to work collaboratively.
Highlight Key Skills: Ensure you mention key skills such as attention to detail, communication, and organisational abilities. These are crucial for the role and should be evident in both your CV and cover letter.
Showcase Collaborative Experience: Since the role involves interfacing with cross-functional teams, include examples of past collaborations in your application. Highlight how you contributed to team success and any mentoring experiences you've had with junior researchers.
How to prepare for a job interview at Stylus Medicine
✨Showcase Your Technical Expertise
Be prepared to discuss your experience with nucleic acids, particularly in developing scalable production processes. Highlight specific projects where you applied fermentation, chromatography, and filtration principles, as these are crucial for the role.
✨Demonstrate Collaborative Skills
Since the position involves interfacing with cross-functional teams, share examples of how you've successfully collaborated with different departments. Emphasise your ability to work with discovery, formulation, and pharmacology teams to achieve project goals.
✨Prepare for Problem-Solving Scenarios
Expect questions that assess your problem-solving abilities. Think of past challenges you've faced in process development and how you overcame them, especially in relation to GMP compliance and technology transfer.
✨Communicate Clearly and Effectively
Strong communication skills are essential for this role. Practice articulating complex scientific concepts in a clear manner, as you'll need to present findings and author study plans. Be ready to discuss how you ensure clarity in documentation and reports.
