Pharmaceuticals: Jobs Available

Perrigo is seeking a Regulatory Affairs Project Manager. This is a full-time job in Allegan, Mich.

Job Description

The person who is hired for this job will:

•  Assemble and review data and information required for ANDA and NDA submissions and amendments for new drug products.

•  Work closely with all relevant departments to ensure availability of proper documents for timely filing of approvable submissions.

•  Communicate with FDA to resolve issues and ensure expeditious approvals and relay information to appropriate groups within company.

•  Assemble and file supplements for ANDAs and NDAs and Annual Reports. Review bioequivalence and clinical study protocols and coordinating studies with CROs.  

•  Implement post-approval activities including labeling and trade dress supplements.

•  Lead or participate in task force activities related to supplements and new applications. Participate in formulation of submissions and approval strategies for projects.

Required Skills

Masters degree in Chemistry, Microbiology, or Pharmaceutical Science and three years experience as Regulatory Affairs Project Manager, Regulatory Affairs Specialist, Regulatory Affairs Associate or related in the pharmaceutical industry or Bachelor's degree in Chemistry, Microbiology, or Pharmaceutical Science and five years progressively responsible experience as Regulatory Affairs Project Manager, Regulatory Affairs Specialist, Regulatory Affairs Associate or related in the pharmaceutical industry required.

Perrigo is an Equal Opportunity Employer.

Pfizer Inc. Is seeking a Principal Scientist for its Kalamazoo, Mich., location. This is a full-time job in pharmaceuticals.

Responsibilities

Pfizer Inc. Is seeking a talented senior scientist to join our efforts in the discovery of novel protein therapeutics for veterinary medicine applications. This job will require an independent thinker with the ability to effectively collaborate with other team members within the department as well colleagues in other technical disciplines.  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. 

Specifically, the incumbent will:

1. Serve as Metabolism & Safety representative/subteam leader for multiple concurrent projects

2.   Design and manage the conduct of in vitro and in vivo studies in laboratory and veterinary species

3.   Ensure that projects receive the correct level of support from all Metabolism and Safety technical disciplines

4.   Ensure timely conduct of quantitative bioanalytical assays for large-molecule compounds

5.   Prepare reports and present results to scientists and management in group settings

Qualifications

Minimum Qualifications:

• PhD in Biology, Biochemistry, Chemistry, Pharmacology, or related discipline with more than 2 years of ndustry experience (or BS/MS with >10 years of industry experience and more than 2 years experience serving as project team representative/subteam leader for drug discovery/development teams)

• Advanced knowledge of PK, PK/PD, pharmacology, and bioanalytical chemistry, particularly for large molecules (proteins/peptides, oligonucleotides, etc.)

• Comprehensive knowledge of methods for quantitative analysis (LC-MS/MS, immunoassays) and biological sample prep for large molecules (proteins/peptides, oligonucleotides, etc.).

• Working knowledge of principles and concepts in adjacent disciplines for biotherapeutic projects (toxicology, molecular biology, protein/peptide chemistry, drug synthesis/formulation, protein expression/characterization, etc.)

• Demonstrated ability to work collaboratively with colleagues in other disciplines on project teams

• Ability to work under minimum supervision and direction

• Excellent written and oral communication skills

• Fluency with Microsoft Outlook, Word, Excel, PowerPoint

Desired Qualifications

• Experience conducting in vitro and in vivo studies

• Experience with radioisotopes (14C and/or 3H), particularly conducting radioisotope-labeled drug disposition studies

• Familiarity with veterinary species (companion animals and food animals)

• Experience with PK modeling and data acquisition software such as WinNONLIN, WATSON, ANALYST, and others

Marketing Statement

Founded in 1849, Pfizer is the world's premier biopharmaceutical company taking new approaches to better health.  Pfizer discovers, develops, manufactures and delivers 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 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.

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.

Perrigo is seeking a QC manager for a full-time position in Allegan, Mich.

Job Description

The person who accepts this position is responsible for the management of all resources (people, equipment, and facilities), establishes standards, processes, and systems for services supporting PMI.  

The incumbent will provide subject matter expertise on events and investigations related to testing for PMI.  

The scope extends to material suppliers and contract manufacturing as needed.  

The person who accepts this position is responsible for Overview, Change Control, and Compliance for the Laboratory programs; cGMP and cGLP Compliance.

The incumbent will be responsible for the development and selection of laboratory and scientific staff.

Along with the approval of laboratory OOT/OOS and excursion investigations.

SME / Deviations/Incidents (Facilities, Manufacturing, Packaging, and/or Suppliers). In addition this position will be responsible for the management of budget resources, support for Production, Business Development, Validation, and/or Stability.

Required Skills

• Bachelor of Science in a related science or specific area is required (Microbiology, Biology, Medical Technology, Chemistry);

• Minimum of six  years of experience with progressive responsibilities and supervision in a cGMP regulated environment;

• Must be able to interpret and apply scientific and regulatory documentation and principles; and

• Must have proven ability to investigate a wide range of manufacturing problems and work closely with a variety of staff in both scientific and production fields; and strong verbal and written communication.

Pfizer is seeking an Associate Director and Manager for its Swine Biological area in Kalamazoo, Mich. This is a full-time management job for a director in the pharmaceutical industry.

Job Description

• Responsible for leading efforts in the design and for implementing swine studies to test the safety and efficacy of biological products. This includes obtaining clinical samples, conducting clinical evaluations and writing of facility procedures and study protocols.

•  Responsible for collecting and maintaining accurate documentation to meet regulatory requirements for conducting swine studies.

•  Responsible for interpreting and correlating clinical results and preparing reports.

• Responsible for participation on research project teams with the goal to license animal health biologics.

• Responsible for establishing contacts with external experts and third party contractors for the conduct of swine studies.

• Up to 25 percent travel is required.

Desired Skills and Experience

Educational Background:
Minimum: DVM or BS/MS
Desirable: PhD or DVM with post-graduate training

Work Experience/Skills

Minimum: DVM with a minimum of two years experience in swine medicine or BS/MS with five years experience in the biological sciences and/or of research in an academic institution or the pharmaceutical industry.

Desirable: PhD or DVM with post-graduate training in swine clinical veterinary medicine or in a scientific discipline relevant to animal disease. Experience as a project leader for biological product research and development.


Other Attributes Desirable:

A good understanding of disease pathogenesis and laboratory clinical assays.
Ability to communicate effectively with colleagues as a member of a multi-disciplinary team.
Demonstration of initiative, independent thinking, strong interpersonal skills and an ability to pay attention to detail.

Ability to meet multiple project timelines.

Company Description

Pfizer is committed to applying science and our global resources to improve health and well-being at every stage of life. We strive to provide access to safe, effective and affordable medicines and related health care services to the people who need them.

Pfizer is seeking a Veterinary Clinical Research Associate in Poultry for its downtown Kalamazoo location. This is a full-time job.

Job Description

The incumbent will be assigned to one or more Project Teams within Clinical Development and will have the following duties and responsibilities:

• Assist with coordination of all study activities, including start up, investigator training, conduct, site monitoring and close out.

These may include, but are not limited to:

• Assisting in preparation of study protocols, data capture forms, test article documentation and study reports.

• Maintaining study files in accordance with SOPs and regulatory requirements.

• Assisting in data management processes including data capture, entry, review, tracking and verification.

• Assisting with animal related study activities (i.e. clinical sampling, test article administration, and clinical observations).

• Serving as the principal communication link between sponsor and study site.

• Travel: Approximately 10 to 40 percent on an annual basis. Variable, depending upon project status.

Work Environment

The person hired for this job works in animal research facilities handling a variety of livestock animals and/or companion animals. There may be exposure to animal wastes, chemicals and biologics and possibly radio-labeled compounds.

Work will be conducted in office, lab, clinic, bio-containment and animal housing facilities. There may be exposure to temperature, climate extremes and dirty and dusty conditions.

Flexible work hours may be required.

Lifting: May be up to 40-60 pounds.

Desired Skills and Experience

Educational Background:

• Minimum: Bachelor's degree in a science field. Bachelor’s degree in a non-science field with at least two year’s experience in the livestock industry, a veterinary technician position, a biological science area, or research experience in an academic institution or the pharmaceutical industry.

• Desirable: Master’s degree

Work Experience/Skills:

• Minimum: Demonstrated organizational and interpersonal skills as well as written and oral communication skills.

• Desirable: Experience and interest in working with poultry is preferred. May also have experience working with livestock including cattle (dairy/beef) and swine, as well as companion animals, which may include horses, dogs, and cats. Previous experience in a research environment (GCP/GLP) and/or previous experience in research/product development in the animal health industry.

Other Desirable Attributes:

Competence in Microsoft Word and Excel. Additional database software experience helpful.

Company Description

Pfizer is a 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 is seeking a Director of Global Alliances, DVM, for Companion Animal Health to be located in Kalamazoo, Mich. This is a full-time position.

Responsibilities

This selected individual will be the primary Global Alliances lead, supporting Pfizer Animal Health’s (PAH) Companion Animal franchise in the U.S. The person who assumes this position will:

• Work closely with the Global Alliances team, U.S. Area President, his leadership team and broader organization plus Veterinary Medicine Research and Development (VMRD), to develop and implement Global Alliances strategies for Companion Animal including developing and implementing innovative strategies to facilitate growth, such as  initiation and running of research consortia focused on issues impacting the health and/or production of Companion Animal species.

• Participate as a member of a variety of Companion Animal focused leadership teams in developing new strategies for developing PAH’s global Companion Animal franchise.

• Work in close coordination with VMRD, PAH’s regional operations and New Product Marketing.

• Identify, establish, build, negotiate and progress suitable alliance opportunities for Companion Animal with academia, research institutes, government, non government and industry organizations globally in collaboration with Veterinary Medicine Research and Development (VMRD) and Commercial Operations.

• Manage and provide regular and timely input on activities impacting the global budget.

• Collaborate with colleagues to share information on opportunities and activities with inter-regional or global relevance, or both.

• Collaborate with Finance, Legal, VMRD, Marketing and Commercial Operations.


The primary duties will include:

• Identifying, building, reviewing, negotiating and assessing alliance opportunities, in collaboration with VMRD Marketing and Commercial Operations, across all business lines -- biologicals, pharmaceuticals and services.

•  Managing global Companion Animal focused alliances to the benefit of regional and global business objectives and supporting the Global PAH  (Pfizer Animal Health) Business through collaborative partnerships with academic experts, research institutes and regional government and non government agencies.

• Working with line manager to ensure that invoices and payments are made according to agreed timing and milestones and that all contractual obligations are met in a timely manner.

Qualifications

• DVM or PhD and MBA required

Two advanced degrees preferred.

Experience

• Partnership development experience in the pharmaceutical, biological and/or biotech sectors required.

• Practical experience and knowledge of the animal health business, particularly the Companion Animal business is preferred.

• Experience with technology assessment, alliances and acquisitions is preferred.

• Experience in negotiating contracts with third parties is preferred.

• A detailed understanding of research planning, experimental design, budget and contract management is essential, as well as strong strategic thinking.

• The demonstrated ability to establish and maintain strong internal and external networks, collaborations and business relationships is essential.

About Pfizer

Founded in 1849, Pfizer is the world's premier biopharmaceutical company taking new approaches to better health.  We discover, develop, manufacture and deliver quality, safe and effective prescription medicines to treat and help prevent disease for both people and animals.