Scientist II, Translational Product Development

What you will do:

As a Scientist II, you will design and conduct experiments, leverage your knowledge of pharmaceutics and formulation, contribute ideas and solutions, and create next-generation drug-loaded polymer products for the Translational Product Development team. This position provides you with ample opportunities to keep abreast of innovative and emerging scientific developments in the pharmaceutical industry by presenting your own work at meetings, attending conferences, contributing to intellectual property, and trialing your ideas in the lab. You will grow professionally through multi-dimensional exposures and experiences and by working with a small, cohesive, highly interactive team on a meaningful venture.

Primary Responsibilities:

• Develop and characterize drug-loaded polymer formulations, with focus on large molecule therapeutics, such as peptides, proteins, monoclonal antibodies, and other biologics
• Ideate approaches to mix and formulate large molecule drugs within crosslinkable thermoset polymers, with an understanding of chemical compatibility
• Study, predict, and characterize drug physiochemical properties and structure-property relationships
• Correlate drug properties, such as particle size, morphology, MW, pKa, pI, and logP, to drug-polymer blend rheology, mixing, and release kinetics
• Quantify large molecule drug release kinetics using appropriate techniques
• Characterize and analyze large molecule drugs that have been released for functionality and bioactivity
• Formulate and fabricate drug-loaded subcutaneous implants, ocular micro-implants, injectable microspheres, oral gastroretentive dosage forms, in situ forming gels, and microneedles for internal platform development and pharma customer projects
• Design and formulate drug-loaded dosage forms to meet various Target Product Profiles while maintaining Critical Quality Attributes
• Analyze formulations using DSC, TGA, NMR, CD, XRD, SEM, FTIR, Raman, and rheometry
• Analyze release media using HPLC, LCMS, GPC, NMR, CD, and bioactivity assays
• Provide technical input on in vivo pharmacokinetic studies
• Contribute to R&D patent portfolio with innovative ideas, present at conferences, and publish articles
• Independently select, design, and/or execute experiments, based on interpretation of previous results and understanding of known theory
• Collaborate with other teams within R&D and across the organization to achieve project goals
• Efficiently coordinate both internal investigations and customer collaborations, progressing multiple projects through to completion quickly
• Make effective decisions to achieve desired outcomes and meet timelines
• Follow all applicable Company test methods, work instructions, SOP’s, and guidelines
• Perform other job-related responsibilities as assigned

Desired Skills:

• Expertise in drug product formulation, ideally sterile or parenteral products with polymer excipients
• Expertise with formulation of biologics, such as peptides, proteins, monoclonal antibodies, and other large molecule therapeutics
• Strong knowledge of analytical and biochemical characterization methods for large molecule drugs
• Experience with large molecule drug suspensions, dispersions, emulsions, complexations, and/or drug-polymer blends
• Experience with techniques such as DSC, TGA, NMR, CD, SEM, FTIR, Raman, HPLC, LCMS, and bioactivity assays
• Demonstrated problem solving ability
• Excellent writing skills
• Strong interpersonal and communication skills

Qualifications:

• Must have formulation experience in the pharmaceutical industry
• Must have experience with large molecule drug formulations
• PharmD or PhD in chemical engineering, biomedical engineering, material science, chemistry, pharmaceutical sciences, or a related discipline with 0-2 years experience, OR MS with 2-4 years experience, OR BS with 4-6 years experience

Work Environment:

• Daily exposure to a chemical lab environment, eye protection, safety footwear and additional PPE, as required.
• Occasional exposure to manufacturing environment and environmentally controlled rooms. Gowning is required to work in these rooms.
• Must follow company Safety Policy and Chemical Hygiene plan
• Adheres to GMP/QSR requirements and follows applicable QMS documentation (e.g., SOP’s, Work Instructions) to successfully accomplish job requirements
• Follows Personal Protective Equipment (PPE) policies and procedures, including wearing hearing protection, safety shoes, gloves, eye protection as required
• Follows gowning procedures in designated areas.
• May be required to be fit for a respirator and adhere to the Respiratory Practice Program, depending on specific chemical handling
• Must be able to work with minimal supervision

Why join us:

We promote collaborative, high energy and fast-paced environment. Using fact-based data, our team members strive to constantly improve our processes and products. We nurture an environment where employees can creatively innovate solutions that drive impactful results both for the business and themselves.

This position includes a compensation package that includes a base salary plus an incentive-based on company and individual performance. We offer a comprehensive benefits package, medical with Rx, life insurance, and 401(k). The Secant Group is an Equal Opportunity Employer. The Secant Group participates in E-Verify as appropriate in accordance with Company guidelines and federal or state law.

The Secant Group utilizes pre-employment drug testing, background checks, and criminal history checks in a manner consistent with all federal, state, and local regulations.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)