Senior Associate - Tech Transfer


Job ID 17-00254

Industry Pharma

Job Type Permanent

Location Denville, NJ

Description

Position Purpose or Objective
The position is a new position and is responsible for all tech transfer activities of new products, process improvement & process optimization of existing products.
Major Areas of Responsibility
- Responsible for formulation development of new products and alternate source API products.
- Transfer of technology for new products from the development or other sites to manufacturing site.
- Responsible for the process validation of submitted/approved products.
- Plan and manage successive phases of developmental and transfer activities.
- Prepare and deliver project proposals and technical support to manufacturing, review of SOP, Protocols, reports etc.
- Responsible for all documentation required for the above activities e. g write and/or approves Standard Operating Procedures, Batch Records, Protocols, Reports, QOS, Strategy documents etc. per 21 CFR guidelines.
- Develops project planning, timelines and logistical programs to match new product launches, contract manufacturing projects and process changes that are required for life cycle management of existing products.
- Assist regulatory affairs department in regulatory submissions.
- Preparation and Execution of cleaning validation protocols.
- Coordinating with other related departments like Quality Control, Quality Assurance, Engineering and Regulatory Affairs.
- Periodic review of SOP and procedures.
- Quarterly and annual inventory reports for DEA controlled substances.
- Initiation of stability studies for formulated trials, monitoring the study and compiling the analytical data.
- Other related activities as per requirement.



Qualifications

Required Knowledge, Skills and Abilities
- Excellent interpersonal skills and ability to establish and maintain effective working relationships with both internal and external stakeholders
- Excellent verbal and written communication skills
- Ability to work with minimal supervision
- Experience establishing and maintaining relationships with key decision makers
- Strong analytical skills and ability to understand business and financial implications of contracts
- Self-directed
Education and Experience
- Minimum BA or BS required
- Minimum 3-5 years of Pharmaceutical Generic Products preferred
Physical Demands
- This position requires the employee to routinely use a computer and telephone.
- Ability to handle the equipment and perform duties in the production area
- Ability and willingness to work additional hours as required by business needs
Work Environment
- General office environment.
- Travel as required.