Job Title

DPI Manufacturing Supervisor

Organization Name

InvaGen Pharmaceuticals, Inc.

Location

Hauppauge, NY location

Employment Type

Full Time

Salary Range

(Base/salary)

$ 70k - $ 80k

Benefits

In addition to a fulfilling career and competitive salary, the Company offers a comprehensive benefits package to include a 401(k) savings plan and matching, health insurance - medical/dental/vision, health savings account (HSA), flexible spending account (FSA), paid time off (PTO) - vacation/sick/flex time, paid holidays, short-term disability (STD), long-term disability (LTD), parental leave, paid and unpaid family leave, employee discounts, and other benefits.

Work Hours/ Shift/ Remote

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.

Responsibilities/ Accountabilities

• 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 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.
• Participate in safety related programs and or safety teams as needed.
• Enforce and follow safety regulations and ensure the working area is clean.
• Adhere to CIPLA's Safety, Health, and Environmental policies.
• Must be able to work under general supervision and able to work independently and in a team environment.
• Must be able to exercise appropriate professional judgment on matters of significance.
• Must be willing to work in a pharmaceutical manufacturing setting.
• Other duties assigned as required by Manufacturing Management.

Education Qualifications

• Master's or Bachelor's degree in Pharmaceutical Engineering, Pharmaceutical Sciences, or related field of study from an accredited college/university required.

Experience

• One (1) to three (3) years of direct work experience in pharmaceutical manufacturing. Preference will be given to candidates with experience in generic pharmaceutical manufacturing.

Skills/ Competencies

• Understanding of granulation, compression, coating, and encapsulation machines
• Capable of conducting troubleshooting, investigations and root cause identification and analysis.
• Capable of handling and participating in compliance and regulatory audits at the local and federal levels.
• Must be proficient in computer skills and software applications such as Microsoft Office tools.
• Experience using SAP business system and applications is a plus.
• Knowledge of statistical packages is a plus.
• Able to effectively lead and manage teams of diverse cultures and backgrounds.
• Able to prioritize, plan and work under tight schedules and deadlines.
• Must possess strong documentation and technical writing skills and be able to apply relevant scientific principles and practices.
• Must communicate clearly and concisely across levels, both orally and in written.
• Strong command over written and verbal English is required.
• Preference for bi-lingual Spanish language proficiency (reading, writing, and speaking).