Formulation and Process Development jobs

A Consultant in the Global Unix/Linux Server Solutions (GULSS) group plays a senior role in formulating technical strategy and architecture for Unix and Linux server platforms including HP-UX, Sun Solaris, and Redhat Linux.

As a subject matter expert, the consultant will provide technical leadership for strategic, complex, multi-disciplined IT projects involving the architecture, testing, and documenting for large scale projects, and will act as an ultimate point of escalation/resolution for complex level III Unix/Linux systems administration issues.

As the third level global support for GULSS, the consultant will work in support of our IT or business clients, providing guidance on best practices for using our services, supporting application deployments, and providing expert level III diagnosis and resolution of production and development problems.

Under general direction of the Manager, Export Management, manages the customer order activity process for an assigned group of countries by receiving and processing routine customer orders. Prepares export documentation and handles complaints and inquiries from global customers to provide maximum customer satisfaction resulting in repeat orders and customer retention.

Basic Qualifications:
-High School Diploma/GED
-2-5 years of international business or export related experience.

Additional Qualifications:
-Working knowledge of Microsfot Excel, Word, PowerPoint & Access.
-Previous AS400 systems preferred
-BS in International Business or related field preferred.

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The Process Engineer II supports the clinical drug product filling operations in the Clinical Fill Finish Facility (CF3). The position is a key member of the CF3 team in the only aseptic fill suite at the Andover campus. The ideal candidate will be able to work in an environment, which requires: organization, flexibility, attention to detail and the ability to balance support of manufacturing operations with timely completion of process/facility improvements and investigations. As a member of the CF3, the candidate will need to effectively interact with other members of the group as well as cross functionally. The position requires the qualification to sterile gown and become media fill qualified to aseptically process drug product. Filling operations will require sterile gowning and aseptic processing for greater than 4 hour periods on a regular basis.

We are seeking an energetic and experienced cell and molecular biologist to join the Cell and Molecular Sciences group, within Drug Substance Development (DSD), to support the BioPharma pipeline through the development of cell lines and cell culture processes for clinical and commercial DS production. The primary responsibilities of the individual will be to contribute as a technical, operational and strategic leader within an organization focused on the generation of highly productive cell lines expressing recombinant therapeutic proteins. Additionally, the group is also responsible for developing novel expression technologies and strategies for improving the level of recombinant protein expression, and the efficiency with which highly productive cell lines and culture processes are developed.

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Perform operations using proper aseptic technique.
• Perform GMP documentation and verification procedures.
• Accountability for assigned laboratories and processes.
• Operation of batching vessels and all associated equipment.

• BASIC QUALIFICATIONS:

• High school education required with good math, computer and science skills.

ADITIONAL QUALIFICATIONS:
• Commitment to documentation and strict adherence to written procedures and GMP policies.
• Ability to follow detailed instructions and SOP’s.
• Previous experience in a manufacturing environment.

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Provides analytical support for characterization of API’s, in-process blend samples and finished drug products in support of the Pharmaceutical Development Center (PDC). Works closely with PDC team members in the design of experiments. Writes comprehensive technical reports describing the results of experiments. Applies creative ability and knowledge of analytical methods and technologies to solve analytical problems. Works on projects that are technically complex. Accountable for the accurate analysis of samples submitted.

Job Responsibilities

Having reached a high level of technical expertise, the incumbent is responsible for moderately complex projects related to the development or application of state-of-the-art processes, equipment, control schemes, and standards, process optimization or transfer of production from development or between commercial sites. Work may include projects and tasks in any or all of the following stages: scope definition, feasibility studies, lab/pilot scale modeling, simulation, cost/benefit analyses, design, specification development, project planning, implementation, and post-implementation monitoring and follow-up. The incumbent must be capable of providing significant contributions to cross-functional projects and may lead some teams with involvement and coaching from their supervisor. Leads Technology Transfer sub-teams when technologies, processes or products are being transferred between commercial manufacturing sites.

Provides analytical support for characterization of API’s, in-process blend samples and finished drug products in support of the Pharmaceutical Development Center (PDC). Works closely with PDC team members in the design of experiments. Writes comprehensive technical reports describing the results of experiments. Applies creative ability and knowledge of analytical methods and technologies to solve analytical problems. Works on projects that have high technical complexity or major scientific importance. Accountable for the accurate analysis of samples submitted as part of requirements.

Having reached a high level of technical expertise, the incumbent is responsible for moderately complex projects related to the development or application of state-of-the-art processes, equipment, control schemes, and standards, process optimization or transfer of production from development or between commercial sites. Work may include projects and tasks in any or all of the following stages: scope definition, feasibility studies, lab/pilot scale modeling, simulation, cost/benefit analyses, design, specification development, project planning, implementation, and post-implementation monitoring and follow-up. The incumbent must be capable of providing significant contributions to cross-functional projects and may lead some teams with involvement and coaching from their supervisor. Leads Technology Transfer sub-teams when technologies, processes or products are being transferred between commercial manufacturing sites.

Provide project leadership and technical oversight for engineers / scientists engaged in carrying out process development activities for Active Pharmaceutical Ingredients (API). Incumbent will have expertise in process development, scale-up, and validation. Responsibilities include assisting the Senior Director- API Process Technology to develop strategy with regard to Quality by Design (QbD) and Process Analytical Technology (PAT) for API use. The incumbent will collaborate with Chemical and Pharmaceutical Development (CPD), the API external supply network and the NP & OE Product Development Centers. Up to 20% travel required.

Job Responsibilities
Provide guidance for project teams engaged in API unit operations development and physical form property definition.
Help devise strategy for API QbD in conjunction with API Tech Ops and CPD leadership for all pipeline projects.
Oversee the development and implementation of PAT tools for API processes at Wyeth and 3rd party sites.