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Job DescriptionThermo Fisher''s clinical research business is a leading global contract research organization and world leader in serving science. We are passionate, deliberate, and driven by our mission - to enable our clients to make the world healthier, safer, and cleaner.Within our Analytical Services team, we have a functional service provider solution, which is an outstanding partnership that allows our customers to use the experience of our staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company, all while maintaining full-time benefits.You will be responsible for supporting analytical activities within Biologics Process Development (PD). The role will involve supporting in-process analytical testing, delivering results within customer and project timelines, assay harmonization activities within the network groups, and evaluation of new analytical technologies. You will have excellent communication skills, is a team player, and have experience in Bioanalytical techniques as they apply to Biologics and related process impurities. Techniques of interest include Capillary Electrophoresis, Liquid Chromatography, and ELISAs. A reasonable appreciation of upstream and downstream process development activities is highly desirable.The role will provide Analytical support within PD. The candidate will work closely with PDA team members and Process Development to deliver quality analytical data in a timely manner.Essential Functions:
Assay support of Biologics Process Development activities using LC, iCE, CE, and ELISA
Work closely with Process Development, Analytical development and testing to support analytical needs and engage in long-term collaboration.
Authors and reviews technical documents and protocols; follows written scientific methods and experimental protocols, documents results, authors, and reviews summary reports.
Run tests and trend assay performances across the Network sites.
Review PD design of experiments.
Support manufacturing site investigations as required.
Our 4i Values:Integrity - Innovation - Intensity - InvolvementIf you resonate with our 4i values above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, submit your application - we’d love to hear from you!Qualifications -Education and Experience:
Bachelor''s degree in Biochemistry, Biotechnology, Analytical Chemistry, or equivalent and relevant formal academic / vocational qualification
Previous experience that provides the knowledge, skills, and abilities to perform the job comparable to 0-2+ years (industry or regulated laboratory preferred)
In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.Knowledge, Skills and Abilities:
Experience in the areas of analytical chemistry/biochemistry, with the emphasis on experience and in-depth working knowledge of LC, iCE, CE and Gel Electrophoresis
Working knowledge of design of experiments and factorial design
Familiarity with upstream and downstream biologics processing
Knowledge of cGMPs as applied to process development and scale up
Development experience for both early- and late-stage molecules is highly desired
Proficient in Microsoft Excel and Word
Proven ability to interpret data by performing trend analysis
Proven ability in technical writing skills
Ability to independently optimize analytical methods
Proven problem solving and troubleshooting abilities
Good written and oral communication skills
Time management and project management skills
Ability to work in a collaborative work environment with a team
Working Environment:PPD, part of Thermo Fisher Scientific values the health and well being of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:
Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
Able to work upright and stationary and/or standing for typical working hours.
Able to lift and move objects up to 25 pounds.
Able to work in non-traditional work environments.
Able to use and learn standard office equipment and technology with proficiency.
May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments.
Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
As a condition of employment with PPD, in this role, you must have received your Covid-19 vaccine and you must disclose proof of your vaccination status upon employment.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
Full-time- ID: #50287449
- State: Massachusetts Devens 01434 Devens USA
- City: Devens
- Salary: USD TBD TBD
- Showed: 2023-09-22
- Deadline: 2023-11-20
- Category: Et cetera