- Islip, NY, USA
InvaGen Pharmaceuticals, Inc. is engaged in the development, manufacture, marketing, and distribution of generic prescription medicines with focus on a range of therapeutic areas, including cardiovascular, anti-infective, CNS, anti-inflammatory, anti-diabetic, and anti-depressants. The company was founded in 2003 and is based in Hauppauge, New York. As of February 18, 2016, InvaGen Pharmaceuticals, Inc. operates as a subsidiary of Cipla (EU) Limited. The company is also referred to as Cipla New York.
The Cipla New York site consists of three manufacturing facilities and a diverse workforce performing a variety of roles such as senior scientist, quality control chemist, quality assurance associate, regulatory affairs analyst, manufacturing and production operators, and other business and technical positions.
Key Job Responsibilities:
Plan, organize and oversee all activities related to the manufacturing of tablets and capsules to include delivery, in-process, and finished product samples in a defined schedule.
Review and compile the documents generated during the production of tablets and capsules such as batch manufacturing records and validation protocols.
Ensure and compliance with safety, quality, productivity, and performance expectations and execution of manufacturing operations.
Provide daily supervision and support to the operators in regarding day-to-day production activities such as trouble shooting and other work tasks.
Coordinate with other departments such as Quality Assurance (QA), Quality Control (QC), Research & Development (R&D), Maintenance & Engineering, Supply Chain and Warehousing, Human Resources, and other internal functional partners with respective to the completion of quality work and achieving the production schedules and performance objectives.
Work with Integrated Product Development (IPD)/R&D on the execution of bio-batches (abbreviated new drug applications - ANDA) and validation batches.
Effective implementation of current good manufacturing practices (cGMP) and safety practices in the operations and manufacturing of products.
Initiate and review written procedures such as standard operating procedures (SOPs), operating instructions, cleaning procedures, safety procedures, and other work procedures as needed.
Manage performance and train assigned employees using Company systems, procedures, policies, practices, and other tools to meet established performance standards, productivity targets, and overall business requirements.
Bachelor's degree in Chemistry, Pharmaceutical Sciences, or related field of study from an accredited college/university.
Three (3) to seven (7) years of direct work experience in pharmaceutical manufacturing. Preference will be given to candidates with experience in generic pharmaceutical manufacturing.
Must be willing and able to work any assigned shift ranging from first, second, or third shift. Work schedule may be Monday to Friday, Tuesday to Saturday, or some combination thereof based on business needs.
Expected Demonstration of Technical Knowledge and Skills:
Understanding of granulation, compression, coating, and encapsulation machines
Capable of conducting trouble-shooting, investigations and root cause identification and analysis.
Capable of handling and participating in compliance and regulatory audits at the local and federal levels.
Expected Demonstration of Professional and Behavioral Competencies:
Able to effectively lead and manage teams of diverse cultures and backgrounds.
Able to prioritize, plan and work under tight schedules and deadlines.
Other Position Requirements and Information:
Must be willing to work in a generic pharmaceutical manufacturing setting.
Must be willing to relocate to the Long Island, NY area and work at the CompanyÃÂ¢ÃÂÃÂs Central Islip and/or Hauppauge, NY sites.
No sponsorship of applicants for work visas.
Preference for bi-lingual Spanish language proficiency (reading, writing, and speaking)
All your information will be kept confidential according to EEO guidelines.