Scientist I-Biopharmaceutical & Bioanalytical Development (Mass Spectrometry)
Want to be part of a company whose goal is to provide outstanding pharmaceutical discovery and development services by creating and using cutting edge science and developing new methods and molecules? Do you want to work with some of the brightest minds in the industry in a rapidly growing company on a trajectory to have a major impact in the life science research arena? We are seeking a talented and passionate Scientist with expertise in Mass Spectrometry who is eager to be part of our success, and who embraces our core values: Integrity, Excellence, and Teamwork. This role requires a highly driven and proactive scientist with a passion for drug development, the curiosity and flexibility to work on diverse projects, and the tenacity to tackle complex questions by developing/applying new methods to solve previously intractable problems in drug development in a dynamic, fast-paced, team-oriented and collaborative environment.
Responsibilities will include, but are not limited to, the following:
- Evaluate the chemical, physical, and biophysical properties of molecules including peptides, proteins, bioconjugates, etc. relevant to biopharmaceutic drug development
- Develop LC-MS methods for analysis or determination of drug substances, degradants, metabolites or biomarkers
- Design and execute assay qualification and validation including the preparation of validation protocols, validation reports and Standard Operating Procedures
- Design and execute experimental plans to support development of client products
- Conduct bioanalytical sample analysis and data review in a GLP-compliant laboratory
- Design and perform experiments to determine the stability in prototype formulations, to detect and identify the decomposition products, and to achieve formulations with acceptable shelf-life.
- Execute and oversee specialized analytical testing and generation of technical documents.
- Maintain a strong awareness of current scientific literature, particularly in the area of protein and other biomolecule characterization, and actively apply new concepts as appropriate.
- Interface with clients to develop an in depth understanding of client objectives and define solutions to meet their program requirements
- Develop compelling approaches and solutions to address client needs
- Write persuasive proposals for the projects
- Regularly interact with clients to keep them abreast of project progress
- Write and review interim and final reports.
- Create presentations for outside scientific meetings and conferences to showcase Wolfe Laboratories’ scientific leadership in the field of biomolecule analysis and characterization.
Required Background and Experience:
- Ph.D. in Bioanalytical Chemistry, Analytical Chemistry or relevant field.
- A minimum of three years of experience in the areas of analytical development, bioanalytical method development and method validation.
- Demonstrated proficiency of LC-MS or LC-MS/MS instrumentation, method development, and data interpretation
- In depth expertise in bioanalytical chemistry and the physicochemical properties of small molecules, and/or peptides, proteins, and biomolecules as they relate to the pre-formulation and formulation development of new drugs
- Understanding and working knowledge of regulatory guidance for bioanalysis and GLP compliance.
- Experience in biopharmaceutical development, lyophilized formulation development, parenteral formulations or novel dosage form design a plus
- Excellent communication, interpersonal and management skills to collaborate with and direct the work of others on assigned projects (including both internal teams and external collaborators) required
- Sound knowledge of related aspects of pharmaceutical research, development, and commercialization processes
- Established knowledge of applicable global drug development and regulatory standards including cGMPs
- Experience preparing technical sections of regulatory submissions and interacting with regulatory authorities on technical matters a plus
- Excellent written and verbal communication skills
Interested candidates are requested to email a copy of their resume with a cover letter including salary history and unofficial transcripts, to: email@example.com.
What we offer:
Wolfe Labs’ employees are innovators with a winning attitude. We offer a fun, multi-cultural environment and value teamwork and accountability through a results-oriented, customer-centric focus. We provide generous health and financial benefits, learning opportunities, competitive compensation, the potential to participate in our employee stock option plan, and a wide range of work/life benefits. Candidates who are keen experimentalists, independent thinkers and enthusiastic team players that have a passion for drug development are encouraged to apply.
For more information visit us at: www.wolfelabs.com
Wolfe Laboratories, Inc is an Equal Employment Opportunity employer.