Planet Pharma ยท 18 hours ago
Senior Associate Scientist, Specifications
Cambridge, MA
Full-time
Onsite
Mid, Senior Level
$42/hr - $48/hr
2+ years expPlanet Pharma is seeking a Senior Associate Scientist, Specifications who will be responsible for specification support of siRNA drug substances and drug products. The role involves managing specification change controls, contributing to regulatory submissions, and maintaining platform program specification documents.
BiotechnologyHealth CarePharmaceutical
Responsibilities
Initiate and manage specification change controls in a GMP setting
Expected contributions to general 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 to data review, 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
Provide support in maintaining platform program specification documents
Meet goals supporting studies and defining specifications for new molecules in development
On-time and compliant completion of review and verification of stability data to support clinical supply
Implementation of stability and release specifications for product registration
Adhere to the companies core values
Qualification
Required
BS or MS in Chemistry, Biochemistry or related disciplines
Minimum of 2 years of previous experience in a cGMP analytical laboratory environment
Must be a team player and open to change
Must have excellent communication and speaking skills. Can prepare presentations and present
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)
Must be able to adhere to all laboratory safety requirements
Must be able to travel between the companies sites
Preferred
Previous experience with stability studies designed and conducted in accordance with ICH guidelines
Experience with HPLC and physico-chemical test methods of oligonucleotides
Alternatively - experience with HPLC and physico-chemical test methods of oligosaccharides or proteins
Company
Planet Pharma
Planet Pharma is a pharmaceuticals company.
1001-5000 employees
H1B Sponsorship
Planet Pharma has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2022 (3)
2021 (5)
2020 (5)
Funding
Current Stage
Late StageLeadership Team
Cynthia Lewis
Senior Executive Recruiter, Life Sciences - PPG Advisory Partners
Emma Morris
President, PPG Advisory Partners
Company data provided by crunchbase