Manager, Manufacturing Operations

Position Summary

Rocket Pharma is seeking a high energy, motivated candidate for Manufacturing Operations Manager.

Candidate will join a well-funded (public, NASDAQ: RCKT) clinical-stage LVV and AAV gene therapy company (biologics) with a broad pipeline in multiple pediatric rare disease clinical indications in US & EU. 

This position is a key role in manufacturing operations.  The ideal candidate will have relevant industry experience in biotechnology, cell, gene or regenerative medicine; or similar industry experience at a leading biotech organization.

As a Manufacturing Operations Manager, you will be responsible for planning, implementing, and monitoring our manufacturing schedule and maximizing efficiency and productivity through resource planning. Additional responsibilities include integrating manufacturing support activities into the schedule planning process, maintaining a safety- and cGMP-compliant manufacturing area, and managing a multi-functional manufacturing team.

The ideal candidate will also have a strong passion and curiosity for science and gene therapy with the desire to bring needed cures from bench to bedside.  Demonstrated genuine interest and curiosity in research and science highly valued.

Primary Responsibilities

  • Plan, implement and monitor the cGMP manufacturing schedule;
  • Collaborate with Supply Chain, Facilities, QC, CMC and QA teams as “customers”;
  • Manage technical transfer from external parties, or for the implementation of new cGMP processes, new cGMP equipment, process improvements and/or process scale-up;
  • Oversee compliance and safety of cGMP manufacturing operations, areas and equipment;
  • Keep detailed records, generate reports, and develop presentations to help senior management understand the manufacturing perspective;
  • Build relationships within the company and with external parties, such as suppliers or vendors;
  • Read and comprehend legal documents, such as contracts or import/export agreements;
  • Understanding of principles of accounting and finance;
  • Collaborate with others from diverse backgrounds in order to identify problems and find solutions;
  • Determine Manufacturing KPIs, establish tools to monitor and report metrics, and implement actions derived from KPIs and metrics;
  • Oversee establishment of cGMP systems and documents;
  • Identify process bottleneck and implement solutions in a timely manner as part of continuous improvement;
  • Train and evaluate others; Provide constructive feedback;
  • Work with Finance, Sales, and Supply Chain team to determine best vendors and distributors;
  • Build and maintain good relationships with vendors;

Job Requirements

  • Demonstrated ability to build and develop a high performing manufacturing organization;
  • Experience managing all aspects of cGMP manufacturing operations, from working cell bank vial thaw to bulk drug substance fill; viral vector manufacturing experience is a plus;
  • Must have experience with GMP/regulated manufacturing environments and materials;
  • Experience establishing cGMP systems and documents;
  • Knowledge and understanding of cGMP facility and utility validation and environmental monitoring;
  • Knowledge and understanding of cGMP equipment validation, operation and maintenance;
  • Hands on experience with manufacturing planning / management software (such as MES/ERP/MRP solutions);
  • Have appropriate understanding of accounting or finance principles and comprehend legal documents;
  • Sense of ownership and pride in your performance and its impact on company’s success;

Education/Experience and Skills required

  • Previous work experience in Pharma/biologics Manufacturing Management for 3+ years;
  • Critical thinker and problem-solving skills;
  • Team player;
  • Good time-management skills;
  • Great interpersonal and communication skills;
  • B.S. or equivalent in Life Science, Biotechnology, ChemE, or similar relevant field; MBA or Master’s level degree is a plus;

Location:  Cranbury, NJ

EEOC

A diverse workforce fosters innovation and strengthens Rocket’s business. We ensure equal opportunity without discrimination or harassment in the workplace on the basis of gender, race, color, religion, national origin, age, physical or mental disability, pregnancy, citizenship, status as a protected veteran, marital status, sexual orientation, gender identity and expression, genetic information, or any other characteristic protected by applicable local, state, and federal laws.

About Rocket Pharma

Rocket Pharma is bringing hope and relief to patients with undertreated rare diseases through establishing a sustainable, integrated, multi-platform curative gene therapy company. We are searching for hands-on team players that enjoy working in extremely collaborative working environments with colleagues that share an excitement for developing innovative technology to treat unmet medical needs. www.rocketpharma.com.

Interested in joining our team? Contact us today!

Resumes with cover letters may be submitted to careers@rocketpharma.com

Interested in joining our team? Contact us today!

Resumes with cover letters may be submitted to careers@rocketpharma.com