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Sr. Associate Scientist Stability

Cambridge, MA 02142

Posted: 08/29/2024 Employment Type: Contract Job Category: Scientific Job Number: 614310 Is job remote?: No Country: United States

Job Description

Job Summary:
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 

The staffing 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 and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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About Cambridge, MA

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Although this hasn't been an issue at Planet Pharma, the staffing 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 and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.