Pharmaceuticals: Jobs Available

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.

Pfizer is seeking a manager of Biological Regulatory Affairs for its Kalamazoo operation. This is a full-time regular position.

Job Description

The person hired for this position will address veterinary biological product registration needs for the United States and will be responsible for ensuring biological products are in compliance with CVB regulatory requirements.

Responsibilities

• Serve as member on multidisciplinary Project Teams responsible for developing veterinary biological products, help develop the regulatory strategy for the team, and be responsible for all US regulatory submissions for that project with significant guidance and mentoring from the Director or Senior Director.

• Serve as a liaison with Biological Discovery to help provide early regulatory input into early phase Discovery projects.

• Liaise with New Product Marketing and the TAs to conduct BOAs and BioScans, and to develop label claims and product supporting materials.

• Responsible for Production Outlines, Special Outlines and required supporting documentation.

• Liaise closely with EU and CLAR/APAC regulatory staff to facilitate global registration where appropriate.

• Serve as an alternate Liaison with USDA.

• Help provide regulatory support for reference requalification.

• Help provide regulatory support and advice regarding PGS initiatives and market enhancements.

• Help provide regulatory support of biological advertisement and promotional materials.

Qualifications

• MS in biology, animal science or other related science.

• PhD or DVM desirable.

• A minimum of 5 years experience with veterinary biological products preferably in regularly affairs or a related area.

• Strong verbal and written communication skills, and a demonstrated ability to work in a team environment.

• Understanding of the veterinary biological development process and USDA regulatory requirements desirable.

• Knowledge in the production and testing of veterinary biological products desirable.

Equal Employment Opportunity

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants.

About Pfizer Inc.

Founded in 1849, Pfizer is the world's premier biopharmaceutical.  At Pfizer, colleagues in more than 90 countries work every day to help people stay happier and healthier longer and to reduce the human and economic burden of disease worldwide.

Pfizer is seeking a Senior Associate Scientist for its Kalamazoo, Mich., operation.

Role Description
Research and develop vaccines for poultry. Perform laboratory studies on cell culture, bacteria and parasite culture. Perform serological assays in order to identify poultry diseases and develop vaccines to combat these diseases. Develop bacterial models of poultry bacterial diseases. Characterize bacteria of poultry importance, recover bacteria from clinical samples of the chicken, and optimize bacterial growth using different media
formulations.

Qualifications
Minimum Education:
B.S. in Microbiology, Biomedical Science or Veterinary Science or related

Minimum Experience:
5 years

Alternative Education / Experience:
M.S. in Microbiology, Biomedical Science or Veterinary Science, one year of experience.

Special skills:
Experience must include: Performing of assays and analyses associated with poultry diseases and bacterial pathogens, including Salmonella, Clostridium, Pasteurella and Haemophilus; Pathogenesis and recognition of clinical signs, sampling methods, and signs of infection associated with those pathogens. Any suitable combination of education, training, or experience is acceptable.

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.

About Pfizer Inc.
Founded in 1849, Pfizer is the world's premier biopharmaceutical company taking new approaches to better health. Pfizer Inc. discovers, develops, manufactures and delivers quality, safe and effective prescription medicines to treat and help prevent disease for both people and animals. It also partners with healthcare providers, governments and local communities around the world to expand access to our medicines and to provide better quality health care and health system support. At Pfizer, colleagues in more than 90 countries work every day to help people stay happier and healthier longer and to reduce the human and economic burden of disease worldwide.

The Perrigo Company in Allegan is seeking an Informics Scientist in Research and Development. This is a full-time position.
             
Job Description                    
                       
The person who is hired for this position serves as the business lead for informatics projects and improvement initiatives by providing technical expertise on informatics related items across GSA-CHC R&D.  

He or she will manage all aspects of the informatics lifecycle to improve efficiency and maximize alignment between GSA-CHC R&D sites and with IT&S.
                   
Required Skills                    
                       
Demonstrated ability to effectively manage the life-cycle of informatics projects of varying complexity and cross-departmental and site scope. This includes, but is not limited to, business requirement identification, vendor selection, ROI assessment, appropriation request preparation, development, validation, training, deployment, continuous improvement, gap identification/remediation and application retirement.   

Demonstrated ability to create a wide variety of technical documentation, including but not limited to functional requirements, design specifications, IQ/OQ/PQ protocols, traceability matrices, User and Administrative process maps, standard operating procedures, and standard work instructions.   

Demonstrated ability to develop an application knowledge base and transfer via training to end Users is required. Familiarity with IT&S Stage Gate project management methodology is preferred. Extensive functional knowledge of R&D informatics systems is preferred.

Strong leadership skills and communication skills are essential to work effectively in interdisciplinary teams and interacting with IT&S.   

A thorough working knowledge of cGMP, cGLP, other US FDA regulations, and ICH guidance documents is essential.  These skills are normally acquired through completion of a bachelor degree in Chemistry or Pharmaceutical Sciences combined with 6+ years of relevant professional experience, or completion of a master degree in Chemistry or Pharmaceutical Sciences combined with 3 to 5 years of relevant professional experience in a cGMP or cGLP laboratory.

Pfizer Inc. is looking for a scientist for its veterinary medicine operation in Kalamazoo, Mich.

Role Description

Pfizer Inc. is seeking a talented scientist to join its efforts in the discovery of novel small molecule and protein therapeutics for veterinary medicine applications.  The successful candidate will have an interest in veterinary applications and have hands-on experience with modern immunoassay methods.  

This job will require an independent thinker with the ability to innovate from the bench and efficiently collaborate with other team members within ones own line as well as the project team.  

Excellent communication skills are essential.  

This position will not have any direct reports and will not require significant travel.  Scientists with a keen interest in Veterinary Medicine and proven research ability are strongly encouraged to apply.

Responsibilities

This position will be responsible for developing ELISA assays and assaying pharmacokinetic study samples to support biopharmaceutical projects.

Qualifications

Minimum skills, education, experience, attributes:
•   BS or MS in biology, cell biology, immunology, biochemistry or related field with a minimum of 3 years experience within the pharmaceutical industry or CRO business.
•   At least 3 years of experience developing, optimizing, and/or validating plate-based ligand binding assays, preferably in biological matrices such as serum.
•   Excellent oral and written communication skills and excellent computer skills.
•   Independent thinker with the ability to innovate within one’s own project and efficiently collaborate with other team members.

Desirable skills, education, experience, attributes
•  Ligand binding assay experience on multiple platforms (traditional ELISA, MesoScale Diagnostics, GyroLab, luminex, etc.) is highly desirable.
•  Experience with automated liquid handling systems and robotics is highly desirable.
•  Experience labeling antibodies with biotin or other tags.
•  Proficiency in modern in vitro laboratory techniques in the area of cellular and molecular biology or immunology.
•  Experience with supporting biotherapeutics teams and/or assay development of therapeutic antibodies.
•  Experience with monitoring work at CROs.

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. All applicants must have authorization to work for Pfizer in the U.S.  

About Pfizer
At Pfizer, colleagues in more than 90 countries work every day to help people stay happier and healthier longer and to reduce the human and economic burden of disease worldwide.

Pfizer Inc. is seeking a Senior Scientist / Principal Scientist. This  a full-time associate position in research and science for the pharmaceutical industry in Kalamazoo, Mich.

RESPONSIBILITIES
The individual selected for this job 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.

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
Minimum skills, education, experience, attributes:
• Ph.D. in analytical chemistry, biochemistry or organic chemistry.
• Excellent knowledge of techniques for extraction and purification of compounds from complex biological matrices.
• Experience with advanced instrumental analysis, especially mass spectroscopy.
• Excellent written and verbal communication skills.
• Ability to work in a team-oriented, matrix environment.

Desirable skills, education, experience, attributes:
• 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. All applicants must have authorization to work for Pfizer in the U.S.

About Pfizer Inc.
Founded in 1849, Pfizer, with operations in 90 countries, is the world's premier biopharmaceutical company taking new approaches to better health. The company discovers, develops, manufactures and delivers quality, safe and effective prescription medicines to treat and help prevent disease for both people and animals. Pfizer also partnesr with healthcare providers, governments and local communities around the world to expand access to our medicines and to provide better quality health care and health system support.

Genemarkers is accepting applications for a Molecular Biology Laboratory Manager. This is a full-time position that will report directly to the company president in Kalamazoo. This is a mid-senior level position in biotechnology.

Job Responsibilities
 • Provides direct supervision of lab staff, including scheduling, staff training, performance management, and monitoring of workflow to ensure lab efficiency.

 • Performs all duties associated with a Molecular Technologist and provides technical coverage including participation in assay development and preparation of maintenance protocols according to company standards.

 • Supervises proper maintenance of laboratory equipment; monitors QA and equipment controls; maintains records and procedures for management requirements.

 • Supervises laboratory supply orders; maintains inventory; generates/updates cost analysis and researches capital purchases.

 • Must be able to communicate both orally and in writing with staff and professional colleagues.

 • Assures that proper competency and training documentation is maintained.

 •  Maintains instrumentation service agreements\warranties and communicates changes to lab personnel.

Desired Skills and Experience
The ideal candidate will be self-motivated, demonstrates the ability to analyze and evaluate innovative ideas, exhibits a collaborative approach and possesses strong communication skills.

• Masters or PhD and a minimum of 5 years experience in relevant field.

• Hands-on experience with RNA/DNA isolation, microarray analysis, qPCR, cell culture, statistics/bioinformatics, knowledge of Next-Gen sequencing a plus.

 • Experience in Molecular Diagnostic Laboratory a plus.

Company Description
Genemarkers is a young, rapidly growing contract research organization located in Kalamazoo, Mich., that specializes in genomics technologies, providing genomics research services to pharmaceutical, biotechnology and personal care companies.

MPI Research is seeking a Research Technician in general toxicology for primates for its headquarters in Mattawan, Mich.

Responsibilities

The person who accepts this position is responsible for providing humane care to all laboratory animals and will perform assigned technical and administrative functions within the guidelines and requirements outlined in a protocol or appropriate Standard Operating Procedure (SOP), thus producing sound, reliable data from which to evaluate the efficacy or toxicity of a test compound.

Duties and Responsibilities (the purpose of the function and result to be accomplished) include but are not limited to:

• Performs basic husbandry functions daily (i.e., feeding/watering, monitoring health).

• Carefully handles animals to prevent injury to technician or animal.

• Administers test article daily via such routes as bolus intravenous injection, subcutaneous injection, oral gavage, and intravenous infusion.

• Collects and documents data daily on an electronic data capture system or appropriate form(s).
• Performs functions used to evaluate the toxicity of the test article (i.e., electrocardiograms, blood pressure measurements, detailed clinical observations, body weight measurements).

• Collects samples periodically (i.e., blood, feces, urine).

• Punctual and reliable attendance according to MPI Research company policy.

Qualifications

•  HS / GED.?

• BS in relevant field.?

• Previous experience working with animals, preferred.?

• Basic computer skills.?

• Computer skills, commensurate with Essential Functions and including ability to learn a validated system.?

• Ability to work extended hours beyond normal work schedule to include, but not limited to, evenings, weekends,?extended shifts and/or extra shifts, sometimes on short notice.?

• Ability to work under specific time constraints.?

Benefits at a Glance
MPI Research provides the following competitive benefits:?

• Three choices of medical coverage, including prescription drug and vision coverage.

•  Two choices of dental coverage?.

• Medical and dependent pre-tax flexible spending accounts.?

• Paid time off bank and holidays?.

•  Retirement savings plan – 401K plan with company matching on employee contributions?.

•  Short/Long term disability plans, voluntary life insurance, and company paid life insurance.

•  Tuition reimbursement program?.

• Employee assistance program?· Employees at MPI Research also are given the opportunity to participate in company-sponsored events, wellness programs, self-directed work teams and open communications programs such as the All Employee Survey.?


About MPI Research

MPI Research, with global headquarters in Mattawan, Michigan, provides discovery, safety evaluation, bioanalytical, and analytical services to the biopharmaceutical, medical device, animal health, and chemical industries. Scientific knowledge and experience, integrity, trust, teamwork, and dedication to strong and enduring Sponsor relationships are the defining attributes that characterize MPI Research as a high-performance, high-quality organization that is committed to bringing safer and more effective products to the world.

Pfizer Inc. is seeking an associate scientist in biology for its Kalamazoo, Mich. location. This is a full-time position.

Role Description
Pfizer is seeking a self-motivated Research associate who is willing to work within a team setting on a variety of projects supporting analytical assays for veterinary vaccine development. This individual will be working primarily in a virology lab, while providing some bacteriological support.

Responsibilities
Responsibilities will include:
• Cell culture
• Preparation of reagents
• Clinical assay support
• in vivo/ in vitro assay development.

Qualifications
• B.S. in Biochemistry, Biology, Immunology, Virology, Microbiology, or related discipline with experience in mammalian tissue/cell culture, virological/bacteriological techniques, and the use of laboratory automation.  
• ELISA experience  is highly desirable.
• Must be willing to work with animals.  
• The candidate must have a strong commitment toward generating high quality data, be able to work under stringent timelines, and have a strong desire to innovate.

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.  

About Pfizer Inc.
Founded in 1849, Pfizer is the world's premier biopharmaceutical company taking new approaches to better health. The company's employees discover, develop, manufacture and deliver quality, safe and effective prescription medicines to treat and help prevent disease for both people and animals.  The company also partners with healthcare providers, governments and local communities around the world to expand access to its medicines and to provide better quality health care and health system support.