Pharmaceuticals / Scientist: 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.

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.

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.