Located in Telford, PA, Secant Group is seeking to fill a Sr. Analytical Chemist position on our New Product Development team. The Sr. Analytical Chemist position is a laboratory-based scientific role in a fast-paced, multidisciplinary team environment. In this role, you will be supporting product formulation and process development for Secant Group’s drug delivery platform utilizing various analytical techniques. Secant’s drug delivery platform is currently focused on controlled release using biomaterials to create long-acting injectable and implantable dosage forms of varying geometries, complexity, and novelty.
As an experienced analyst, you will design and conduct experiments, bring knowledge of GLP/GMP working techniques, mentor junior scientists to best practices in industry, and lead analytical efforts for the New Product Development team. You will have the opportunity to work with teams comprised of scientists and non-scientists to effectively coordinate internal efforts and customer requests, while progressing multiple projects through to completion quickly. This position provides you with ample opportunities to keep abreast of innovative and novel scientific developments in the pharmaceutical industry by presenting your own work at meetings, attending conferences, reading relevant literature, and trialing your ideas in the lab.
Develop methods for analyzing drug release from API-loaded polymers, designed for long-acting implantables
Analyze dissolution media containing API and polymers, particularly insoluble polymers
Separation of APIs from polymers and polymer fragments for analysis on LCMS and GPC
Extraction of APIs from polymers for analysis on LCMS
Digestion of polymers for analysis on LCMS and GPC
Validate sample preparation methods, including separation techniques
Validate analytical methods for LCMS, GPC, and GC
Daily runs using LCMS, GPC, and GC
Use understanding of pKa, isoelectric point, pH, ionization, logP, and/or molecular weight of analytes, polymers, surfactants, and buffers to achieve efficiency, retention, and separation for LCMS and GPC
Develop dissolution methods to accelerate multi-month drug release studies
Develop predictive in vitro-in vivo correlations between dissolution data and pre-clinical pharmacokinetic data
Explore drug-polymer miscibility for various hydrophilic and hydrophobic APIs
Formulate various hydrophilic and hydrophobic APIs in polymers, and analyze drug release, for long-acting implantables
Make formulation recommendations based on findings
Use FTIR to determine API-polymer mixing and distribution
Use FTIR to determine API-polymer adducts and other reaction products
Independently select, design, and/or execute experiments, based on interpretation of previous results and understanding of known theory
Contribute to innovative approaches to achieve project goals
Collaborate with other teams within and outside of R&D to achieve project goals
Make effective decisions to achieve desired outcomes of immediate work group
Anticipate/recognize potential problems with equipment and/or supplies, and initiate action to solve or prevent problems
Follows all applicable Company test methods, work instructions, S.O.P.’s, and guidelines
Performs other job related responsibilities as assigned
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 requited 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
Must have worked in the pharmaceutical industry for at least 1-2 years
Must have knowledge of GLP and/or GMP as it applies to analytical chemistry
Must have experience with separation chemistry, particularly separating APIs from polymers
Must have experience developing and validating LCMS methods
Must have strong knowledge of polymer-API interactions
Experience with analytical techniques such as HPLC, MS, GC, GPC, UV, IR, Karl Fischer, and dissolution, with proven ability to troubleshoot these methodologies
Familiarity with authoring relevant analytical sections of a regulatory submission
Demonstrated problem solving ability
Excellent writing skills
Strong interpersonal and communication skills
PhD in chemistry, chemical engineering, biochemistry, or a related discipline with 1-2 years experience, OR MS in chemistry, chemical engineering, biochemistry, or a related discipline with 4-5 years experience, OR BS in chemistry, chemical engineering, biochemistry, or a related discipline with 6 years experience
About Secant Group
The Secant Group is an advanced technology biomaterials company headquartered in Telford, Pennsylvania, with manufacturing facilities in Quakertown and Perkasie, Pennsylvania. Secant provides innovative solutions through next-generation materials, structures, textile designs, and process technologies for the medical device, pharmaceutical, aerospace and energy markets.