At a Glance
- Tasks: Lead CMC strategy for client programmes and ensure regulatory alignment.
- Company: Join Pharmaron, a global leader in life sciences with a collaborative culture.
- Benefits: Competitive salary, vibrant work environment, and opportunities for personal growth.
- Other info: Dynamic team atmosphere with a focus on innovation and employee support.
- Why this job: Make a real impact in drug development and work with cutting-edge biologics.
- Qualifications: PhD or MSc in Life Sciences and 10+ years of relevant experience.
The predicted salary is between 51750 - 63250 £ per year.
Location: Liverpool
Pharmaron is a global CRO helping pharma and biotech companies bring new therapies to life. With over 25,000 employees worldwide across 28 locations in the US, UK and China, we support drug discovery through to manufacturing with fully integrated, high-quality services. We’re proud of the impact we make and just last year, we supported over 780 discovery projects, 1,000+ CMC programmes, and 1,000+ clinical trials across all phases.
About the Role
We have a new opening for an Associate Director, CMC Lead on a 12 Month Fixed Term Contract to lead the CMC strategy for client programs, ensuring alignment with regulatory expectations and successful progression through development and licensure. This successful candidate will act as a technical and strategic bridge between customers and functional teams (Process Sciences, Analytical Sciences, Manufacturing) and ensure effective strategy for delivery of client programs both internally and externally. The candidate will also be expected to deliver high-quality consultancy and submission support to both customers and internal teams.
At Pharmaron we offer:
- Vibrant and dynamic employment – we are a highly specialised, growth company operating in a critical sector of the economy – our future is strong and exciting!
- Opportunities to develop your skills and yourself – our rapid growth brings greater opportunities for you to learn and grow faster!
- A great team where we all support each other – enjoy your work – after all you spend about a third of your time here!
Key roles and responsibilities:
- Lead CMC strategy for assigned client programs across development stages (early development through to commercialisation).
- Responsible for ensuring alignment of development, manufacturing and control strategies with current global regulatory expectations (MHRA, EMA, FDA).
- Lead preparation and/or review of CMC regulatory submission dossiers for the customer and review, manage and interpret regulatory guidance and translate into practical development and control strategies.
- Act as CMC sponsor on client projects, lead and support the project team to ensure robust and phase-appropriate control strategies are in place and risks to regulatory submissions are flagged and managed.
- Oversee validation activities for manufacturing processes, analytical methods, and cleaning procedures to align with customer needs, regulatory guidance and internal procedures.
- Provide consultancy services to customers and support project delivery by overseeing the technical design and reporting of CMC technical studies including process and analytical tech transfer, product comparability, process characterisation, and process validation.
- Responsible for identifying regulatory trends and implementing changes within the organisation and internal procedures.
- Creates strategy for external partnering and collaboration as appropriate for internal/client requirements and oversees delivery.
Requirements:
- PhD or MSc in Life Sciences discipline or equivalent industrial experience.
- 10+ years experience including significant experience leading process and analytical transfer activities for development and GMP projects within the biotechnology industry as well as extensive CMC leadership across multiple/highly complex biologics programs.
- Experience supporting process validation, analytical validation, and GMP manufacturing and risk management approaches.
- Strong knowledge of global CMC regulations.
- Clear understanding of science and a passion for keeping abreast of regulatory and industry changes across multi-modalities.
- Experienced in the manufacturing and testing of multi-modality biologics.
- Knowledge of GMP and Quality Management Systems.
Why Pharmaron?
Collaborative Culture: Thrive in our inclusive and collaborative environment, where teamwork and innovation go hand in hand. Here, your voice matters, and your contributions make a real impact. "Employees Number One" and "Clients Centered" are the core cultural values at Pharmaron. Our culture, which sets Pharmaron apart from other organizations, has evolved from our deep commitment to our employees, partners and collaborators.
Pharmaron is a premier service provider for the life sciences industry. Founded in 2004, Pharmaron has invested in its people and facilities and established a broad spectrum of research, development, and manufacturing service capabilities throughout the entire drug discovery, preclinical, and clinical development process across multiple therapeutic modalities, including small molecules, biologics, and CGT products. With over 25,000 employees and operations in the U.S., the U.K. and China, Pharmaron has an excellent track record in delivering R&D solutions to its partners in North America, Europe, Japan, and China.
Salary: Competitive
Frequency: Annual
Contract Type: Fixed-Term Contract
Closing Date: No expiry date
Job Category: Scientific (Biologics Development, Manufacturing & Control Operations)
Associate Director, CMC Lead – Biologics (12 Month Fixed Term Contract) in Liverpool employer: Pharmaron
Pharmaron is an exceptional employer located in Hoddesdon, offering a dynamic and collaborative work environment that fosters innovation in drug discovery. With a strong emphasis on employee growth and development, team members are encouraged to enhance their skills and advance their careers while contributing to impactful projects in bioanalysis and biotransformation. The company's commitment to high-quality data generation and a supportive culture makes it an ideal place for passionate scientists to thrive.
StudySmarter Expert Advice🤫
We think this is how you could land Associate Director, CMC Lead – Biologics (12 Month Fixed Term Contract) in Liverpool
✨Join Biotechnology Meetups
Get yourself into the loop by joining local biotech meetups or workshops. These events are perfect for making connections with professionals in the field and can often lead to temporary gigs through word-of-mouth. Plus, you'll get to hear about the latest trends and developments directly from the source.
✨Showcase Your Passion in Science
Consider starting a blog or social media channel to showcase your interest in biotechnology. Share the latest research, your insights, and even your projects. This will not only enhance your visibility in the community but also attract potential employers like Pharmaron who might be scrolling through for talent.
✨Tap into University Resources
If you’re still in school or recently graduated, don’t forget to use your university’s career services. They often have exclusive connections with companies looking for temporary staff. Reach out to them for internship listings and networking opportunities tailored to the biotech sector.
✨Apply Directly on Our Website
When you spot that perfect temporary role at Pharmaron, make sure to apply directly through our website. This way, you’ll be in the best position to get noticed quickly and can show your enthusiasm for the role while filling out the application.
We think you need these skills to ace Associate Director, CMC Lead – Biologics (12 Month Fixed Term Contract) in Liverpool
Some tips for your application 🫡
Showcase Relevant Lab Skills:In the biotech world, your lab skills are paramount. Make sure your CV highlights specific techniques and equipment you’ve used, such as PCR, gel electrophoresis, or cell culture. This will give us a clear picture of what you can bring to Pharmaron as a temporary teammate.
Highlight Your Research Experience:If you’ve worked on any research projects — whether during your studies or in previous positions — make sure to detail these in your application. Include the objective, your role, and what you achieved. This will help us see your potential and fit for the temporary position at Pharmaron.
Keep It Concise and Relevant:Especially for a temporary role, we want to see a clear and focused application. Tailor your CV and cover letter to emphasise the qualifications and experiences that are most relevant to the biotech field and the specific role at Pharmaron. This shows us you’re genuinely interested and capable.
Be Clear About Your Availability:Since it’s a temporary role, let us know right away when you’re available to start and how long you can commit. Include this in your cover letter — this kind of transparency saves us all time and helps us find the right fit quickly at Pharmaron.
How to prepare for a job interview at Pharmaron
✨Brush Up on Your Biotech Basics
Understanding the fundamental concepts in biotechnology is crucial. Be ready to discuss core topics like genetics, molecular biology, or bioinformatics, especially if you're asked technical questions. We suggest revisiting your coursework or recent projects to refresh your memory.
✨Demonstrate Your Adaptability
Since this is a temporary role, they’re likely looking for someone who can jump in and get up to speed quickly. Share experiences where you’ve adapted to new environments, tools, or teams in a short space of time. It shows you're ready to tackle the challenge head-on!
✨Emphasise Your Lab Experience
If you’ve got hands-on experience in lab settings, now’s the time to showcase it. Talk about specific techniques you’ve mastered, like PCR or chromatography, and any relevant safety protocols you’ve followed. These details help paint you as an effective team member from day one.
✨Be Prepared to Explain Your Passion
Hiring managers want to see your motivation, especially for a temporary position in a fast-paced field like biotechnology. Be ready to discuss what excites you about the industry, your career goals, and how this role at Pharmaron aligns with them. It’s all about showing that you’re not just looking for a job, but a stepping stone in your biotech journey.
