(Senior) Principal Research Scientist, Preformulation

Job Description

The Biologics Preformulation and Drug Development Group is an integral part of the Drug Product Development Organization. The primary function of the Preformulation Group is to evaluate the properties of biological drug candidates designed for specific therapeutic targets and to promote the appropriate discovery candidates with the highest likelihood of success into full CMC development. We have an exciting and unique opportunity for an experienced Biologics Development Leader based in Worcester, MA.

Key Responsibilities Include:

• Designs experiments, strategies and workflows to evaluate physicochemical properties of new biologic entities (antibodies, bispecific antibodies, antibody drug conjugates, fusion proteins) to identify any liabilities that could impact drug substance and drug product development.
• Demonstrates a thorough understanding of protein biophysical stability in solution and the basic elements of rational formulation design. Ability to solve tough formulation problems within a matrix environment or explain limitations of a formulation to project teams and management.
• Ability to apply principals of biophysical characterization to unique proteins and novel formats. Working within a matrix environment, able to design characterization workflows for novel biologics for selection to full CMC development.
• Takes initiative to develop independent research ideas and pursues scientific questions that may arise during preformulation studies. Presents data at internal and external professional conferences and prepares manuscripts for publication in peer reviewed journals or patent applications. Supports and contributes to ongoing independent research projects and technical writing of reports and manuscripts in the Preformulation Group.
• Ability to build and manage strategic alignments with key stakeholders, revise and improve business workflows, manage project timelines and resources. Develops the optimal CMC development path for assigned discovery projects together with clients from various discovery and development functions with an emphasis on collaboration, quality and with a sense of urgency.
• Operates in a matrix team environment, aligning across and executing shared departmental and divisional strategies. Additionally, the candidate has the communication skills, confidence and experience to influence strategic outcomes with stakeholders and matrix teams as needed.
• Manages a team of 5 to 7 skilled PhD and MS scientists. Emphasizes efficient work habits, strong collaboration inside and outside the group and managerial transparency. Establishes attainable career development pathways for group scientists.
• Thorough understanding or ability to learn the technologies routinely used in biophysical characterization of proteins and formulation development. Takes initiative to evaluate new technologies to maintain state-of-the-art analytical capabilities.
• Acts as a liaison with IT groups. Recommends improvements and manages information technologies to keep the Preformulation group current which includes SharePoint sites, electronic notebook templates and interfaces with data repositories. Data mining and basic computational chemistry skills are a bonus.

Basic:

• BS, MS, or PhD in Pharmaceutical Sciences (or equivalent i.e. Chemical Engineering, Biochemistry Biophysics) with at least 18+ (BS), 16+ (MS) or 10+ (Ph.D.) years of industry experience.
• Proven experience of early and late stage drug product development process is required; experience on drug substance development is a plus.
• The ideal candidate will have demonstrated experience with a broad range of analytical methods including mass spectrometry, liquid chromatography (SEC, CEX, HIC, semi-prep), AUC, DSC, UV-vis and fluorescence spectroscopy, vibrational spectroscopy, MALS, DLS, charge measurement, ICD. Must be willing and able to learn new technologies as needed.
• In-depth knowledge about the biophysics of proteins in solution including colloidal interactions, structure thermodynamics, viscosity theory is required. In-depth knowledge of protein formulation.
• Computational chemistry and structural and mathematical or statistical modeling skills are a plus.
• Due to close interactions with multiple partner functions such as biologics drug discovery, drug product formulation and drug substance manufacturing, excellent communication skills are essential.
• The ideal candidate must be proficient with technical writing of internal reports and external publications and presentatio ns.

• Significant Work Activities and Conditions: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
• Travel: Yes, 10 % of the Time
• Job Type: Experienced
• Schedule: Full-time
• Job Level Code: D