Catalent Pharma Solutions Principal Scientist, Bioanalytical Development in Boston, Massachusetts
Catalent hires people with a passion to make a difference to the health of millions of people globally. Your expertise, coupled with Catalent’s advanced technologies and collaboration with thousands of innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives. Interested in learning more about life at Catalent? Start here (http://www.catalent.com/index.php/about-us/Catalent-Careers2)
The Principal Scientist, Bioanalytical Development, will support Catalent Biologics for the development and manufacturing of client products and processes. The network role is a new one and will be an exciting opportunity to align best practices and build capability. Responsibilities include supporting cross functional efforts at 2 of the US DP Biologics sites by driving and sustaining formulation and drug product process development linked to manufacturing. Collaboration with the broader US and EU biologics leads will also be important. A strong collaborator is needed who will work effectively across functions and sites. The Principal Scientist will be based in the US and will report to the Director, Integrated Network and will also work with the site PD Directors. Some travel to relevant sites will eventually be needed to evaluate capabilities and implement projects. The Scientist can work remotely if desired and may not need to relocate.
Lead and support biologics analytical development and method transfer for client programs.
Apply biochemical and biophysical methods as needed for routine testing and deep characterization.
Assess transferred methods and develop new protein analytical methods.
Assure work is informed by knowledge of molecule structure function and biochemistry and protein degradation mechanisms
Collaborate with QC to assure that stability work is effectively planned and informed by biologics molecular structure.
Using statistical knowledge and understanding of phase appropriate needs guide decisions and/or impact of specifications.
Actively contributes to the strategic direction of the biologics network by recommending expansion or curtailment of investigations based on experimental results or scientific information.
Collaborate on technical transfer and scale-up support with MS&T and operations across as needed across the network.
Support client visits and working teams.
Applies technical, functional, and industry knowledge to design and evaluate methods via DOE/QbD approach, review and analyze data, frame early and late phase needs.
Review technical documents for accuracy, thoroughness and regulatory compliance
Train, coach, and mentor others in BIO development/MS&T and quality control.
Participates in or leads client meetings offering technical support and leading the project; collaborate with other Catalent team members.
Develop and administer training webinars and courses for analytical development including planning and leading internal and external workshops.
Routinely suggests new, innovative solutions to routine and complex problems.
Support strategic efforts for new and evolving methods.
PhD in Chemistry, Biochemistry, or related scientific field with 8+ years of related industry experience.
MSc in Chemistry, Biochemistry, or related scientific field with 12+ years of related industry experience.
Experience in bioanalytical development, deep knowledge of biologics analytical development strategies and familiar with current industry best practices.
Experience in biochemical and biophysical methods for biologics molecular structure routine testing and deep characterization. Familiar with the relationship of biologics molecular structure to stability.
Experience developing protein analytical methods including characterizing degradation of biologics molecule, familiar with biologics drug product degradation mechanism.
Familiar with the fill finish process impact to the biologics product quality.
Experience with preparation of regulatory documents including FDA (BLAs, INDs, briefing documents) and EMA (CTD, MAA) and ICH Guidelines.
Demonstrated problem solving skills and written/verbal communication skills
Ability to work independently within a team environment.
Demonstrated interpersonal skills to build relationships, act as change agent, and adapt to rapidly changing organizational and business needs.
8-12+ years of experience related experience required and GMP experience preferred
Catalent’s standard leadership competencies that are used to interview and for Performance & Development:
Leads with Integrity and Respect
Demonstrates Business Acumen
Fosters Collaboration and Teamwork
Engages and Inspires
Coaches and Develops
Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.
Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone’s safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.
personal initiative. dynamic pace. meaningful work.Visit www.catalent.com/careers to explore career opportunities.
Catalent is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation or gender identity. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.
Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.
Catalent = Catalyst + Talent
Your talents, ideas, and passion are essential to our mission: to develop, manufacture, and supply products that help people live better, healthier lives. Join us!
personal initiative. dynamic pace. meaningful work.
Catalent is the perfect place to grow your career if…
You enjoy the fast pace of a start-up, but want the opportunities and stability of a growing, publicly traded company (Listed on NYSE: CTLT).
You want meaningful work. From cough treatments to cancer-fighting drugs, biologics, and vitamins, we help develop, launch, and supply over 200 new products each year – more than any branded drug maker in the world!
You want to plant your career in a growing company. Over the last five years, Catalent has re-invested more than $2 billion back into the company and its people.
You are excited about learning, collaborating, and growing alongside a global diverse team. Our team of more than 11,000 comes to work every day ready to overcome new challenges with teamwork, advanced technologies, and a passion to deliver by putting patients first.
You want to make a global impact! From North America to Europe, Asia to Latin America, we have innovative science and manufacturing teams who are looking (https://catalent.wd1.myworkdayjobs.com/External) for YOU!
See how our teams are making a difference, while growing their careers and fulfilling our mission by putting patients first every day here (https://www.youtube.com/playlist?list=PLuUGqEwwnH7hBwFlrsfSOH_raQHu4hOBK) .
Catalent is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected veteran status. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email along with the job number and title to Jobs@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be routed to a recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.
Catalent Pharma Solutions
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