ProMetic BioTherapeutics Inc. (« PBT ») is responsible for the US development and commercialization of the manufacturing process that provides for highly efficient extraction and purification of therapeutic proteins from human plasma in order to develop best-in-class therapeutics.
The Analytical Chemistry Department of ProMetic BioTherapeutics Inc. is looking for a Formulation Scientist to work at its location in Rockville, Maryland. Under the supervision of the Associate Director, Assay Support, the Formulation Scientist will be responsible for the design and optimization formulation of drug delivery systems to support combination product development, preclinical and clinical studies. This person is also responsible for characterizing physicochemical properties such as physical form, solubility, stability, and interaction of drug molecules with excipients. This includes experimental planning, design, data analysis and interpretation.
The mandate of the Formulation Scientist will be mainly to:
- Support the design and definition of formulations used in late phase clinical studies and post-market authorization;
- Participate in the development of robust scalable manufacturing processes and support technology transfers to commercial manufacturing facilities;
- Support the preparation and review of product development reports and related documents;
- Participate in the development of new technologies and enhanced technology capability applicable to solid dosage form development and commercialization;
- Maintain laboratory documentation in accordance to requirements;
- Write CMC sections to support IDE and PMA submissions for combination products;
- Participate in cross-functional product development teams and provide technical support when necessary;
- Consistently generate innovative and unique solutions to market need and submit idea disclosures in order to develop new or refined products, processes or equipment;
- Select techniques to solve complex problems and make sound design recommendations;
- Assay method development and validation;
- Release and perform stability testing at internal and external laboratories;
- Develop and evaluate formulations, processes, and equipment;
- Execute Quality by Design of Experiments principles in product and process development;
- Write protocols and batch records to carry out process development and evaluation work, scale up and pivotal batch manufacturing for IND submissions;
- Participate in identifying manufacturing equipment, conducting scale-up studies and supporting existing products;
- Assist Regulatory Affairs in preparation of INDs;
- Maintain appropriate documentation of primary data records, report sheets and laboratory notebooks as required by SOPs;
- Ensure compliance and carry out responsibilities in accordance with the organization's policies, procedures, and state, federal, and local laws.
The selected candidate will hold a Master’s degree in Technical Discipline (PhD preferred) with six (6) to ten (10) years’ experience preferably in a biopharmaceutical industry. Deep understanding of pharmaceutics and physical chemistry is a must. Experiences in practical lab-based Pharmacokinetics/Pharmacodynamics data analysis and in pre-clinical model development are desirable asset.
The following criteria are also required:
- Good understanding of cell biology, pharmacology, and biochemistry;
- Substantial knowledge in assay method development and validation;
- Familiarity with release and stability testing;
- Ability to collaborate effectively in team;
- Strong interpersonal and communication skills;
- Good technical writing skills.
ProMetic offers a competitive compensation, a flexible work schedule and a casual working environment.
To apply, please send a cover letter and a copy of your resume to firstname.lastname@example.org with the following reference: FORM-PBT. ProMetic is an equal opportunity employer. Only chosen candidates will be contacted for an interview. For more information about ProMetic, visit our website www.prometic.com.