Research and Innovation / Scientist: Jobs Available

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CeeTox seeks scientist in Kalamazoo

Posted 4122 days ago
CeeTox is seeking a Scientist 1 for its Kalamazoo operation. 
 
Job Description
This position is responsible for performing routine assays for client projects and development and maintenance of automated Biomek platform.
 
Duties and responsibilities
1. Performs standard assays according to SOPs
2. Develop and maintain automated Biomek platform
3. Performs specialty assays with guidance of senior scientists
4. Understands biochemistry of each assay, knows range of acceptability, and can identify experimental or procedural errors and perform limited troubleshooting
5. Enters data and performs Quality Control of data
6. Operates automated equipment and understands key parameters of each instrument
7. Responsible for maintaining detailed experiment, analysis, and project notes
8. Follow all CeeTox SOP’s
9. Maintain confidentiality in accordance with CeeTox Confidentiality Agreement
10. Perform other duties as requested
 
Desired Skills and Experience
General qualifications and educational requirements
• Bachelor’s with 3 years of laboratory experience (e.g., biochemical assays) Required OR  Master’s with 1 year of laboratory experience (e.g., biochemical assays) Required
• Experience with automated platforms (e.g., Biomek) and software (e.g., SAMI), must be a Beckman Coulter automation system.
• Computer and software skills.
• Excellent time management skills.
• Excellent written and verbal communication skills.
 
Physical Demands
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this Job, the employee is regularly required to sit and talk or hear. The employee is frequently required to use hands to finger, handle, or feel and reach with hands and arms. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, depth perception and ability to adjust focus.
 
Company Description
CeeTox, Inc. a NAMSA Company, provides a unique and robust in vitro toxicity screening approach designed to improve the discovery process and support the pharmaceutical, chemical, cosmetic, and biotech industries globally.
 
For more than 45 years, NAMSA has been a world-leader specializing in the safety evaluation of medical devices. NAMSA helps medical device manufacturers market safe and effective products. Our unique combination of preclinical and clinical expertise means we deliver the most cost effective testing programs that satisfy regulatory requirements worldwide. Specific capabilities include regulatory consulting, materials characterization, function and performance studies, biocompatibility, clinical research services, and sterility assurance. 
 
NAMSA also develops and manufactures biological indicators, growth promotion test suspensions, and chemical process indicators. U.S. laboratories are ISO 13485 certified. NAMSA's laboratory in Lyon, France is accredited according to ISO 17025.

Pfizer seeks Principal Scientist

Posted 4143 days ago
Pfizer is seeking a Principal Scientist for its Kalamazoo operation. 
 
Responsibilities
 
BS/Ph.D.:  The selected individual will be responsible for the planning and execution of a wide range of studies in the area of Human Food Safety including total residue analysis, metabolic profiling and analytical method development in primarily livestock species and to a lesser extent in laboratory species. Hands-on laboratory work with complex biological matrices (plasma, excreta, tissues) is anticipated.  
 
The candidate will be responsible for writing the technical reports associated with these studies and presenting/defending the data to government officials (FDA) responsible for dossier review and registration. 
 
Ph.D.:  The candidate will participate on project teams and sub-teams as molecules move through the development process.  
 
Supervisory experience is not required, but a desire to assume management responsibilities at some future date would be considered a positive attribute.
 
Qualifications
 
B.S. in analytical chemistry, biochemistry or organic chemistry with 10 years (+) experience in an industrial setting (pharmaceutical, chemical, environmental) and an emphasis in drug metabolism (in vitro and in vivo) techniques. 
OR 
Ph.D. in analytical chemistry, biochemistry or organic chemistry with associated drug metabolism experience. 
 
B.S./Ph.D.:  Advanced knowledge of techniques for extraction and purification of compounds from complex biological matrices 
 
Experience with advanced instrumental analysis, especially chromatography and mass spectroscopy. 
 
Excellent written and verbal communication skills. 
 
Ability to work in a team-oriented, matrix environment. 
 
Desirable skills, education, experience, attributes: 
 
For Ph.D. level, some experience in an industrial setting (e.g. 1-3 years employment; internships) 
 
1-3 years post-doctoral experience in medicinal chemistry and/or drug metabolism. 
 
Working knowledge of GLPs and ability and desire to work in a highly regulated environment.
 
Experience with interacting with external organizations, especially governmental groups.
 
Working knowledge of the animal health industry, especially in the area of food safety.
 
Experience with working with radioactive molecules.
 
Supervisory Experience.
 
Equal Employment Opportunity
 
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.  Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. 
 
 
As one of the global leaders in the biopharmaceutical industry, Pfizer is committed to seeking out inspired new talent who share our core values and mission of making the world a healthier place.
 

Perrigo seeking scientist in research and development

Posted 4290 days ago
Perrigo Co. of Allegan is seeking a scientist for research and development.

Job Description
Provides technical support to assigned projects, using robust scientific methods which comply with standard operating procedures and scientific standards.  Works with limited direction.  As appropriate, may serve as a project leader to manage analytical support for projects with minimal supervision.

   1.    Prepare documents for regulatory filings (ANDA, NDA, ANDS).  Design experiments and provide data to support responses for FDA minor deficiency letters.

   2.    Perform physical and chemical testing on raw material, in-process, finished product and stability samples.  This includes documentation and review.

   3.    Successfully investigate and resolve analytical problems, project issues and deviations.  Accurately maintain all related documentation in compliance with SOPs.

   4.    Research, prepare and review technical documents, including but not limited to SOPs, drug master files, technical packages, vendor qualification, raw material and release and stability specifications, stability summaries, test methods, and certificates of analysis which conform to company standards.

   5.    Attend and present data at project-related meetings, interact with other departments and outside testing laboratories to ensure proper analytical testing.

   6.    Participate in cross-functional project teams, and exercise and build basic team effectiveness skills.

   7.    Utilize skills, established procedures, new methodologies, and experience to complete tasks; and provide formal and informal mentoring to junior team members.

   8.    Develop, validate and transfer non-complex to complex analytical methods.
Required Skills

Demonstrated proficiency in the use of a variety of standard analytical instruments, such as HPLC, UPLC, GC, Dissolution, UV-Vis and AA.  

Demonstrated proficiency in the use of instrument software applications.  Familiarity with a variety of compendial references, including USP or European Pharmacopeia.  The ability to develop, document and execute analyses or experiments of moderate complexity, ensuring methods are robust and reliable.  

The ability to maintain high quality research documentation, analyze and interpret data, and prepare reports, qualification documents, SOPs or other technical reports is necessary.   

Must be able to work independently on multiple concurrent projects, and communicate effectively with interdisciplinary project teams.

Required Experience
These required skills are normally acquired through completion of a bachelor degree in Chemistry or Pharmaceutical Sciences combined with 4 to 6 years of relevant experience in a cGMP or cGLP laboratory, or a master degree in Chemistry or Pharmaceutical Sciences combined with 0 to 2 years of relevant experience in a cGMP or cGLP laboratory.

Research scientist sought by Perrigo

Posted 4388 days ago
The Perrigo Co. is seeking a senior research scientist for its Allegan, Mich., location. This is a full-time position.

Job Description
This hands-on position will work on multiple projects simultaneously involving multiple dosage forms.
Projects may include any combination of the following: new RX to OTC switch products, line extensions, sustained release projects, and reformulations. Along with related departments, the scientists will champion the formulation development, technology transfers (from formulation/lab scale to pilot plant and commercial scale), stability, scale-up, coordination of ANDA submissions and validation of all products.
The scientist will work very closely with the manufacturing operators and technicians to focus on process innovations and improvements.
The person in this position is responsible for leading product/process development, manufacture of clinical trial material, scale-up and commercialization activities for new immediate release and modified release solid oral dosage for multiple products and liquid oral dose products.
Lead the manufacture of Pivotal/Registration lots for new products.
Prepare or co-author Product Development documents for inclusion into the eCTD and Quality Overall Summary (QOS).
The Senior Scientist will be required to mentor junior level scientist and technicians in the design and execution of quality scientific experimentations to develop robust solid dosage and possibly liquid dosage form formulas.  
Will perform effective problem solving, resolution and implementation of process improvements in designated day-to-day operations and participate in large scope product/process development and projects.
This position will need to communicate effectively with the project manager and the larger development team and provide key timeline information, present data at team and departmental technical meetings.  

Required Skills
Must be knowledgeable of cGMP’s, understand tablet development and manufacturing and related equipment, have a strong ability to plan, organize, and execute projects, with excellent verbal and written communication skills.
Experience with liquid, semi-solid and suspension products a plus.
Perform effective problem solving, resolution, and implementation of process improvements. Lead and/or collaborates with multidisciplinary teams to resolve complex product development issues and respond to internal and external audits.
Offer innovative solutions to improve product development methods or solve specific technical problems.

Required Experience
Bachelor’s degree in Pharmaceutical Sciences, Chemical Engineering or closely related life sciences discipline combined with seve to eight years of relevant experience in the pharmaceutical industry, or a Masters degree combined with five to six years of relevant experience, or a doctoral degree Pharmaceutical Sciences, Chemical Engineering or closely related life sciences discipline combined with one to three years of research experience in the pharmaceutical industry.

MPI looking for scientist in immunology

Posted 4556 days ago

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