Lead QC, R&D Pilot Plant

Job Title:                                  Lead QC, R&D Pilot Plant

FLSA Classification:               Professional, Exempt 

Work Location:                        Fall River, MA

Work Hours:                            General: 8:30AM – 5:00PM (may vary based on business needs)

Reports To:                              Director of Quality Control

Purpose:

Invagen Pharmaceuticals is searching for experienced candidates for the position of Senior Manager, MDI ADL.  This person will provide managerial support and technical expertise to drive business functions for pilot plant in Fall River, MA.

Scope:                        

The Senior Manager, MDI ADL will manage and drive analytical activities for the global market respiratory MDI projects throughout the development life cycle to ensure timely submission as per the regulatory norms and business needs.

The job duties for this position include but are not limited to the following:

1. Pilot plant analytical method development Lab Setup

• Will serve as a technical expert to train the technicians.
• Will help to hire and develop the staff.
• Will manage the preparation and reviewing of all SOPs for Lab setup.
• Area allocation for Instruments and analytical activities.
• Will supervise the workflow.
• Ensures safe, productive laboratory facilities.

2. Maintenance and calibration of lab instruments / equipment to get accurate and reproducible analytical result for proper interpretation

• Maintain the lab instruments / equipment and troubleshoot the issues.
• Review of calibration (schedule / breakdown)
• Review of HPLC/GC/IC columns as per cGLP
• Other duties as assigned.

3. Develop and monitor new vendor
   • Shortlist the vendors.
   • Conduct due diligence of vendor.
   • Frequent communication with vendors on the required designs.
   • Identify and shortlist the provider.
   • Monitor the progress of the system and timely communicate with vendor for successful outcome.

4. Lead the group to deliver the HFA152a product project

• • Schedule, track and document all quality control testing of raw materials and reagents.
  • Monitor daily activities and support the delivery of key strategic products for IPD.
  • Interact with departments across IPD to understand the requirements as per the project.
  • Ensure compliance to relevant regulations and quality norms.
  • Ensure on time and accurate documentation of the development process across its various stages.
  • Conduct investigation and root-cause analysis.

5. Key Interactions

6. Education and Experience

• Bachelor’s degree in chemistry (analytical and technical chemistry).  
• Master’s degree in chemistry preferred.
• At least 15 years’ experience in MDI Lab.
• Knowledge of MDI analytical tests.
• Experience in managing a team.

7. Technical Knowledge and Computer Systems Skills

• 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.
• Experience in Inhalation products (MDI) is a plus.

8. Professional and Behavioral Competencies

• Communication and presentation skill
• Cross functional collaboration
• Interpersonal skills to handle difficult and confidential issues
• Proficiently speak English as a first or second language
• Ability to understand and analyze complex data sets.
• Knowledge of good manufacturing practices and good documentation practices preferred.

• Self-motivated, with the ability to work in a fast-paced manufacturing environment and handle multiple tasks simultaneously.
• Excellent organizational skills with the ability to focus on details.
• Basic computer skills (Word and Excel) – Intermediate

9. Work Schedule and Other Position Information

• Must be willing to work in a pharmaceutical manufacturing setting.
• Must be willing to work some weekends based on business needs as required by management.
• Relocation negotiable.
• No remote work available.

GLOBAL COMPANY

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.

Cipla employs handpicked professionals not just for their knowledge and experience but for their zeal to make a difference to the world of healthcare.  The company believes that our biggest assets are the employees who lead us to prosperity and growth in the future.  Driven by the vision, none shall be denied, Cipla’s focus has always been on making affordable, world-class medicines with a reputation for uncompromising quality standards across the world.

CIPLA NEW YORK (INVAGEN PHARMACEUTICALS, INC.)

About InvaGen Pharmaceuticals, a Cipla subsidiary 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 Central Islip and Hauppauge, New York. As of February 18, 2016, InvaGen Pharmaceuticals, Inc. operates as a subsidiary of Cipla (EU) Limited.

Cipla, Inc is an equal opportunity and affirmative action employer committed to building an inclusive and diverse workforce.