]SUMMARY:
The Senior Scientist I will be responsible for early and late stage drug product development activities ranging from formulation, process development, optimization, and scale-up of small molecule oral dosage form. This individual will oversee and coordinate activities in lab and provide support in technology transfer, scale-up, process validation, and commercialization. This individual must have a “take charge”, “lead by example” attitude, and excellent communication skills. The applicant also must possess a solid track record of working in a high potency lab, deep underlying technical problem-solving skills and creative thinking in small molecule oral solid dosage form development. He/she will be working in a fast pace internal/external cross functional team environment, be able to present technical data to leadership team, and support manufacturing of CTM batches at third party manufacturers for early and late stage programs.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Develop oral solid dosage form for oncology products using various formulation technologies.
Design formulation development studies including lab scale and scale-up manufacturing processes for oral solid dosage form.
Identify, critical quality attributes and process parameters and implement appropriate process controls for the manufacturing process.
Work in high potency lab using PAPR and appropriate lab safety procedures.
Troubleshooting skills in formulation/process issues for oral solid dosage forms.
Apply methodical approach in selection of vehicles, excipients and/or new technologies appropriate to prepare formulations of novel investigational small molecules to support non-clinical studies.
Apply statistical design of experiments to optimize and scale-up formulations and manufacturing process.
Knowledge of enabling technologies such as solid dispersion, lipid or microemulsion, oral liquid formulation is a plus.
Participation in project teams and internal/external collaborations, and preparation and review of regulatory/CMC documents.
Possess excellent writing and verbal communication skills and strong interpersonal skills.
SUPERVISORY RESPONSIBILITIES:
None
EDUCATION/EXPERIENCE/SKILLS:
Education:
BS/BA degree in pharmaceutics, or pharmaceutical sciences, bioengineering, biophysics, chemical engineering and seven years of related experience; or,
MS/MA degree in pharmaceutics, or pharmaceutical sciences, bioengineering, biophysics, chemical engineering and five years of related experience; or,
PhD in pharmaceutics, or pharmaceutical sciences, bioengineering, biophysics, chemical engineering, and zero or more years of related experience, or;
Equivalent combination of education and experience.
Experience:
Experience in Pharmaceutical/Biotech industry preferred.
Must have proven skills in the areas of solid oral drug product formulation development.
Hands on experience in high shear granulation, roller compaction, direct compression, aqueous and solvent-based coating is required.
Experience with statistical tools to design and evaluate experiments for formulation and process development preferred.
Experience with other dosage forms or advanced formulations (e.g. controlled release) is a plus.
Operation 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 optimzation/scale up of solid oral dosage forms.
Strong knowledge and experience of the various phases of drug development for oral dosage forms is required.
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.
Proficient with broad use of computer applications such as MS Office.
Applies strong analytical and excellent verbal and written communication skills.
Identifies and implements methods and procedures to achieve results.
Performs a variety of complicated tasks with a wide degree of creativity and latitude.
Has complete understanding and wide application of technical principles, theories, concepts and techniques.
Has 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 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.
WORKING CONDITIONS:
Environment: Primarily working in office
Travel required – 10% of domestic/international travel required
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If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us!
Our compensation reflects the cost of labor across several U.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this position is $116,000 - $165,500 annually. The base pay range may take into account the candidate’s geographic region, which will adjust the pay depending on the specific work location. The base pay offered will take into account the candidate’s geographic region, job-related knowledge, skills, experience and internal equity, among other factors.In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year.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.