Senior Formulations Scientist II
$71K-$129K (Glassdoor est.)
Position Description

This Senior Formulations Scientist II position will be responsible for early and late stage drug product development activities including formulation, process development, optimization, and scale-up of small molecule oral dosage form. This individual will also manage operational activities with the contract manufacturing organizations (CMOs), including technology transfer, formulation/process optimization, troubleshooting, scale-up, and process validation. This person should possess extensive knowledge and experience in technical assessment for selection and onboarding new CMOs. In addition, responsibilities include participating and collaborating with internal acnd external project teams, preparing and reviewing regulatory and Chemistry Manufacturing & Control (CMC) documents. This individual must have a “take charge” and “lead by example” attitude, a solid track record of dealing with external manufacturing, and deep underlying technical skills in small molecule products. This individual must also have excellent command skills, complex problem-solving abilities, outstanding communication skills, and the ability to apply creative solutions to solve complex issues.

Position Requirements

ESSENTIAL DUTIES AND RESPONSIBILITIES:
•Select vehicles, excipients and/or new technologies appropriate to prepare formulations of novel investigational small molecules for in vivo studies.
•As the formulation and manufacutring process Subject Matter Expert, provide on-site technical support as “person-in-plant” during critical formulation/process developmenet activities and manufacturing of clinical trial materials at CMOs as needed.
•Evaluate physico-chemical characteristics of small molecules such as pH, pKa, solubility, pH-solubility profile, particle size, solid and solution state stability studies, excipient compatibility, dissolution characteristics and polymorphism.
•Design and implement experimental protocols to select prototype formulations to support toxicokinetic and pharmacokinetic studies including stability data analysis.
•Design experimental studies to select formulation and process for Phase I First In Human Clinical trial including selection of protype formulation, stability, and manufacture of clinical trial material (CTM).
•Apply statistical design of experiments to optimize and scale-up formulations and manufacturing process.
•Manage technology transfers for scale-up, process validation, and clinical manufacture of Phase I, II and III supplies including troubleshooting issues with formulation and manufacturing processes..
•Assess technical capability of a potentially new CMOs to support early and late stage drug product development activities.
•Create criteria for the CMO selection process.
•Author and review IND quality eCTD modules for new molecule.
•Manage development timelines for multiple molecule projects.

SUPERVISORY RESPONSIBILITIES:
•None

EDUCATION/EXPERIENCE/SKILLS:
Education:
•MS/MA degree in bioengineering, biophysics, chemical engineering, pharmaceutics, or pharmaceutical sciences and five years of related experience; or,
•PhD in bioengineering, biophysics, chemical engineering, pharmaceutics, or pharmaceutical sciences and two years of related experience, or;
•Equivalent combination of education and experience.
•May require certification in assigned area.

Experience:
•Typically requires a minimum of ten years of related experience and/or combination of experience and education/training.
•Experience in Biotech/Pharmaceutical industry preferred.
•Demonstrated experience in successfully working with CMOs for current Good Manufacturing Practices (cGMP) clinical supplies manufacuring. Responsibilities include the preparation, review and approval of a broad spectrum of technical documents, including Manufacturing Batch Records (MBRs), specifications, protocols, reports, and etc.
•Must have proven skills in the areas of solid state characterization.
•Extensive experience in technical assessment and selection of CMOs for early and late stage drug product development.
•Experience in developing oral and hands on experience in particle sizing, fluid bed granulation, roller compaction, direct compression, aqueous and solvent-based coating is required.
•Previous participation in project teams and internal/external collaborations, and preparation and review of regulatory/CMC documents are also important aspects of this position.
•Must be able to provide thorough formulation analysis results in a timely manner.
•Experience with other dosage forms or advanced formulations (e.g., controlled release) is a plus.
•Strong experience with solid-state characterization and analytical instrumentation.
•Operation and maintenance of various scientific instrumentation such as, High Performance Liquid Chromotography (HPLC), Fournier Transfer Infrared Spectroscopy (FTIR), Thermogravirmetric Analysis (TGA), and Differential Scanning Calorimeter (DSC), etc. is a plus.

Knowledge/Skills/Abilities:
•Knowledge of formulation development and process optimization/scale up and validation of solid oral dosage forms.
•Strong knowledge of and experience of the various phases of drug development for oral dosage forms is required.
•Ability to manage multiple project assignments and function in a driven and fast moving team environment.
•Familiarity and working knowledge of current Good Manufacturing Practices (cGMP)/International Conference on Harmonization (ICH) regulations, with experience working in a GMP facility is required.
•Experience with statistical tools to design and evaluate experiments for formulation and process development. Proficient with use of statistical software such as JMP or Minitab.
•Leads the work of others by providing guidance to subordinates or teams based on organizational goals and company policy, with responsibility for results, costs, methods and staffing.
•Proficient with broad use of computer applications such as MS Office.
•Applies strong analytical and excellent verbal and written communication skills.
•Possesses extensive experience in relevant industry/profession and area of specialization.
•Utilizes professional concepts and company objectives to resolve complex issues in creative and effective ways.
•Identifies and implements methods and procedures to achieve results.
•Performs a variety of complicated tasks with a wide degree of creativity and latitude.
•Possesses complete understanding and wide application of technical principles, theories, concepts and technique and has a good general knowledge of other related disciplines.
•Applies strong analytical and business communication skills.

JOB COMPLEXITY:
•Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors.
•Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation of criteria for obtaining results.
•Uses professional concepts and company’s policies and procedures to solve a wide range of difficult problems in imaginative and practical ways.
•Networks with key contacts outside own area of expertise.

DISCLAIMER
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.

We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.
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