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Sr. Associate Scientist Stability
675 West Kendall Street Cambridge, MA 02142 US
Job Description
The Senior Associate Scientist, Stability and Specifications will be responsible for stability and specification support of siRNA drug substances and drug products.
Summary of Key Responsibilities:
?Initiate and manage specification change controls in a GMP setting.
?Expected contributions to general laboratory operations including review of data and authorship/review of technical documentation. Provide technical support as needed.
?Author and review SOPs and protocols in accordance with company and regulatory guidelines.
?Contribute data to analytical and stability sections of regulatory submissions. Assist with responses to agency requests on these sections.
?Contribute to specification assessment of existing and new products.
?Provie support in maintaining platform program specification documents.
Accountabilities:
?Meet goals supporting studies and defining specifications for new molecules in development.
?On-time and compliant completion of stability data to support clinical supply.
?Implementation of stability and specifications for product registration.
Competencies:
?Ability to write clear technical documents and provide meaningful presentations.
?Ability to work independently and in compliance with company policies and regulatory guidelines.
?Excellent team skills, organization, and strong interpersonal communication skills (written and verbal)
Knowledge/Experience/Skill:
?BS or MS in Chemistry, Biochemistry or related disciplines.
?Minimum of 2 years of previous experience in a cGMP analytical laboratory environment.
?Preferred previous experience with stability studies designed and conducted in accordance with ICH guidelines.
?Must be a team player and open to change.
?Must have excellent communication and speaking skills. Can prepare presentations and present.
?Preferred – experience with HPLC and physico-chemical test methods of oligonucleotides. Alternatively - experience with HPLC and physico-chemical test methods of oligosaccharides or proteins.
Physical/Environmental Factors:
?Must be able to adhere to all laboratory safety requirements
?Must be able to travel between sites
Pay ranges between $25-28.90/hr for this position
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
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