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Assay Development Leader Direct Hire MA
Job ID: 14731 Direct Hire MA
Our client is a mid-sized, high-profile drug discovery company with a novel platform. They are seeking an experienced Assay Development leader to join their growing team as they continue to develop multiple therapeutics and prepare for commercialization. This role will be based initially in Cambridge and will move to the suburbs of Boston as they open a new site.
The main function of this role is to help develop and implement in vitro molecular, biochemical, physiochemical, analytical, microbiological and cellular assay methods designed to characterize preclinical material with an an eye to eventual GMP methods as pipeline products move towards commercialization.
Responsibilities include but are not limited to;
• Identify and implement modifications to existing assays to improve performance and metrics
• Perform data analysis to ascertain agreement with acceptance criteria, identify data trends, and troubleshoot data inconsistencies
• Manage daily activities for small preclinical assay development group
Formal descriptions can be supplied for interested candidates.
Qualified candidates will have PhD in Analytical Chemistry, Biochemistry or related discipline and 5+ years of industry experience. BS/MS candidates with 10+ years of relevant experience are also welcome. Must have extensive knowledge and hands-on experience in method development, performance, optimization and qualification of a broad array of in vitro assays used to characterize oligonucleotides, peptides, or biologic therapeutics.
Must be authorized to work in the US indefinitely to be considered and must be commutable to the Cambridge area or able to relocate with very limited assistance.
All resumes will be kept strictly confidential until you choose to pursue a specific opportunity with one of our clients.
Sr. Scientist, Formulations (Biologics) Direct Hire MA
Job ID: 14480 Direct Hire MA
Mid-Size Biologics company here in Cambridge, MA is expanding their elite Drug Product Process Development and Manufacturing team! They are looking to onboard Scientists (Scientist through Principal level) with biologics protein formulation and drug product experience as their drug pipeline continues to grow! Scientists will be responsible for conducting experiments to develop formulation and optimize manufacturing processes. In addition these roles will play a critical part of a team involved in process development, characterization, optimization including associated scale-up, technology transfer, manufacturing, and validation activities.
- Ph.D. with 3+ years or MS with 7+ years of experience and in a scientific discipline (pharmaceutical science or chemical engineering, preferred).
- Demonstrated ability to work in the lab and execute experiments.
- Excellent communication skills including the ability to write technical reports and summarize data from experiments.
- Attention to detail and ability to work in a fast-paced, dynamic, environment.
- Practical experience in biologics drug product process development, characterization, technology transfer, and manufacturing required.
- Ability to manage external CMO’s and Partners is a plus.
Director, Formulation Development (Biologics) Direct Hire MA
Job ID: 14326 Direct Hire MA
Mid-Size Biologics company seeking Director, Formulation Development their Drug Product Process Development team! The successful candidate will be responsible for strategic planning, coordinating, and execution of the drug product process development / characterization activities, as well as oversight of contractors for process development, including associated scale-up, process optimization, technology transfer, manufacturing, and/or validation activities.
Director, Formulation Development will work closely with cross-functional teams and leaders concerning projects, operational decisions, and scheduling requirements and will conduct briefings and technical meetings for internal and external representatives including equivalent or above management. This position will represent the company’s drug product process development and manufacturing to both internal and external organizations, including CMO/CROs and partners.
- M.S. or PhD in a scientific discipline (pharmaceutical science, chemical engineering, or life science) and 10+ years’ experience in a development environment.
- Demonstrated technical project leadership skills
- Experience in drug product process development and characterization; lyophilization experience is a plus
- Experience in cGMP, aseptic manufacturing of parenteral drug products.
- Experience in technology transfer and management of contract manufacturers is a plus.
- Strong understanding of drug delivery options