Job Title Unit Head of Packaging
Organization Name InvaGen Pharmaceuticals, Inc.
Location Central Islip, NY location
Employment Type
Full Time/Salaried Exempt
Salary Range
$98,000 - $116,350
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
The work schedule will be Monday to Friday during day shift only. No remote work available. Extended work weeks include Saturdays and/or Sundays or holidays as requested or required based on business needs.
Responsibilities/ Accountabilities
* Prepare, review and monitor the execution of packaging plan in coordination with other departments by considering product demand and available resources to facilitate smooth operations and meet production target and timeline.
* Review the available resources, packing requirements & forecasts as per the packing plan and monitor its implementation.
* Review planned v/s actual output as per schedule.
* Liaise with cross-functional teams for release of analysis of batches/packing. material, dispatch of finished product, and to get the approved documents triggered through QMS.
* Monitor the adherence to safety standards & statutory compliance to create a safe working environment.
* Review safety systems and procedures to be followed in plant in coordination with HSE department.
* Evaluate and mitigate potential hazards in the department by tracking all incidents/accidents and implementing CAPAs.
* Ensure safety training completion in the department by coordinating with HSE department.
* Ensure that the machine maintenance is carried out as per standard and adequate stock of spare is maintained to achieve smooth and trouble-free operation adhering to the budget.
* Review processes to close maintenance issues by coordinating with the engineering department.
* Partner with OEM/Spare parts vendors to ensure cost effective procurement as well as remote/on-site support when needed.
* Ensure the procurements & development of imported machine spares through local vendors using technical expertise & maintain adequate stock to eliminate downtime.
* Monitor and optimize the utilization of packaging consumables.
* Ensure facility upkeep to adhere to cGMP and regulatory compliance.
* Ensure the integrity of online documentation & compliance to cGMP for fulfilling regulatory requirements.
* Approve cGMP documents before handing them over to QA.
* Review the change controls and communicate their impact on documents and facility to QA and Engineering.
* Maintain the integrity of documentation during regulatory and customer audits.
* Ensure training is imparted on documentation, critical process parameters, changes being made & failures or deviations to adhere to cGMP requirements.
* Identify all the failures with regards to equipment, facility, packing operation, people resources, including pertinent assumption, identifying the potential risk to have adequate control measure.
* Participate in self-inspection and internal audit to review the documents and systems against the predefined standards.
* Ensure the compliance of the action plan generated from cross-functional meetings like QMR, GMP, safety and process improvement.
* Drive continuous improvements such as reduction in process cycle time, increase machine speed for the identified product through unit operational studies, which will lead to debottlenecking the capacity.
* Conduct unit operational studies to find improvement areas and implement new development projects.
* Optimize machine speed by technical development & operation simplification.
* Evaluate machine upgrade potential to meet quality standards with enhanced productivity.
* Suggest SKU reduction to enhance productivity by simplifying packaging operation.
* Mentor and coach the teams by imparting the training at all levels. to avoid operating error, adhering to GMP practices in-process failure, and energy saving.
* Schedule and conduct training to all shop floor staff to understand cGMP and safety requirements.
* Train the manpower for change room practices, personal hygiene, and other related SOP.
* Provide awareness training on energy saving, warning letter & other regulatory information.
* Provide insights to all concerned people on any market complaint received at unit, site, or other locations.
* Maintaining full knowledge and a strong understanding of all SOPs and proper use of equipment.
* Be a point of contact for questions regarding procedures and expectations for employees.
* Serves as a leader and coach.
* Addresses performance issues via coaching and/or partnering with HR when necessary.
* Approve time off through ADP. Follow safety regulations and ensure the working area is clean.
* Adhere to CIPLA's Safety, Health, and Environmental policies.
* Other duties may be assigned.
Education Qualifications
* A minimum of a bachelor's degree in engineering, business or a related area.
Experience
* At least eight (8) years of experience in the generic pharmaceutical industry managing packaging operations, CGMP and regulatory requirements.
* Must have cGMP experience, preferably within the pharmaceutical industry.
Skills/ Competencies
* Strong verbal and written communications.
* Self-starter with the ability to work in a fast-paced environment.
* Demonstrated ability to lead, motivate and coach large teams, including people managers.
* Must be proactive and take initiative to ensure the completion of quality staff work.
* Must be able to influence at the shop-floor operational and senior leadership levels.
* Able to partner, facilitate, and collaborate with employees and managers across the organization.
* Must be able to exercise appropriate professional judgment on matters of significance.
* Able to compile, analyze, and report data in a business context with attention to detail, understanding trends, and developing recommendations based on the data analysis.
* Proficient user of Microsoft Office tools such as Word, Excel, PowerPoint, Outlook, Teams Meeting, and other business software.
* Proficiency in Spanish a plus.
Physical Demands
* Must be willing to start work early or stay late past scheduled work hours based on business needs, if required.
* Must be willing to work weekends and/or holidays based on business need and as required by management.
* Must be able to travel domestically and internationally as needed - less than 20%
* This role works in a cGMP laboratory or manufacturing environment, where personal protective equipment is required, which may include uniforms, lab coats, safety glasses, respiratory protective equipment, hearing protection, etc.
* Sitting at a desk and/or working at a computer or other "screen" 25% or greater of an 8-hour period.
* Able to wear appropriate personal protective equipment (PPE) or gear when required, such as respirators, gowns, lab coats, safety shoes and/or boots, safety glasses and goggles, gloves, or shields.
* The work requires some physical exertion such as long periods of standing; walking over rough, uneven, or rocky surfaces; recurring bending, crouching, stooping, stretching, reaching, or similar activities.
* The position may require heavy physical work such as heavy lifting, pushing, or pulling required objects up to 50 pounds with or without assistance.
* The work may require specific, but common, physical characteristics and abilities such as above-average agility and dexterity to include the ability to frequently stand, bend, walk, sit, climb, balance, stoop or crouch, kneel, reach, push, pull, feel, talk, write, type, listen and hear.
About Cipla
Cipla is a leading global pharmaceutical company, dedicated to high-quality, branded, and generic medicines. We are trusted by healthcare professionals and patients across geographies. Over the last eight decades, we have strengthened our leadership in India's pharmaceutical industry and fortified our promise of strengthening our global focus by consolidating and deepening our presence in the key markets of India, South Africa, the U.S., and other economies of the emerging world. Driven by the purpose of 'Caring for Life', Cipla's focus has always been on making affordable, world-class medicines with a reputation for uncompromising quality standards across the world. In the last 85 + years, Cipla has emerged as one of the most respected pharmaceutical names in India as well as across more than 100 countries. Cipla is a fast-growing pharmaceutical company with a continued focus on the expanse of our strong legacy. Over the last five years, Cipla has significantly expanded its portfolio and presence in the U.S. with both a generic and brand division.
InvaGen Pharmaceuticals, Inc.
InvaGen Pharmaceuticals is a Cipla subsidiary 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 Central Islip and Hauppauge, New York. In October 2020, InvaGen established its project site in Fall River, Massachusetts to support the launch of Cipla's respiratory business in the United States.
Equal Opportunity Employer
Cipla is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status. At Cipla, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require reasonable accommodation to make your application or interview experience a great one, please contact the recruiter.
About the Salary/ Pay Range:
The salary range mentioned above is an anticipated base salary range for this position. Exact salary depends on several factors such as experience, skills, education, and budget. Salary range may vary based on geographic location. In addition to base salary, this position may be eligible for benefits and participation in a bonus program based on performance and company results.
Cipla USA
flexible benefit account, parental leave, paid time off, paid holidays, flex time, 401(k), remote work
Jan 22, 2025