Manager, Manufacturing Technical Services (Union City)

Full Time
Union City, GA 30291
Posted
Job description
Overview:

Who we are.
Dendreon is making the battle against cancer personal. Founded on the belief that the immune system holds the key to the future of cancer care, Dendreon is committed to the delivery of treatments that harness the power of the body’s immune system to attack cancer cells.


If you are looking to positively impact the lives of patients, we want you to join our team. Headquartered in Seal Beach, California, and with sizable locations in Union City (Greater Atlanta), Georgia and Seattle, Washington, as well as countrywide Commercial and Medical Science Liaisons teams, we have a diverse offering of exciting opportunities.


What we do.

Vision – Pioneering the future of immunotherapy.
Mission – Making the battle against cancer personal through immunotherapy treatments that extend lives.


How we do it.

The Dendreon Way. We are a purpose-driven, value-based culture. At Dendreon, we…

  • Put Patients First: Every day is a new opportunity to improve the lives of patients living with cancer.
  • Act with Integrity: Be honest, transparent, and committed to doing what’s right in every situation.
  • Build Trust: Building trust takes time. Engage teammates, be candid and transparent.
  • Raise the Bar: Harness continuous improvement, foster innovation and elevate our people.
  • Drive Results: Be accountable and execute – we win when everyone performs.

Primed for Growth - Contract/Partner Manufacturing Business Unit.

Dendreon has been working in the cellular immunotherapy space for over 10 years and brings all the experiences that comes with developing a complex manufacturing process from clinical development through to consistent commercial production. Dendreon is unmatched in its patient logistics/operational functions, manufacturing excellence in cellular therapies and commercial sales team for cellular immunotherapies. Given this expertise, we plan to leverage these strengths to grow Dendreon's pipeline of products initially through contract manufacturing for partners and then patient operations and eventually commercial sales.


Are you ready?

Our high-performing organization challenges, develops, and rewards employees interested in pushing past typical career limitations. If you are passionate about helping patients and looking for a unique career opportunity, view our open positions to apply or refer a friend today.


Job Summary:

This Manufacturing Technical Services Manager position manages the site wide capacity planning, materials management, and shop floor execution functions that support clinical and commercial manufacturing at Dendreon’s Union City Immunotherapy Manufacturing Facility (IMF). The manager will establish production plans, monitor and coordinate manufacturing, testing and release schedules, and oversee the day-to-day activities of the GMP warehouse.

In addition, this position will assist with monitoring performance metrics and various manufacturing continuous improvement projects; and manage training programs for new and existing manufacturing operations associates, coordinators, and supervisors.
Responsibilities:
  • Works with the cross functional Dendreon Operations team to ensure cGMP compliance and FDA inspection readiness
  • Manage IMF scheduling staff and ensure timely execution of the day-to-day production activities
  • Work closely with Patient Scheduling Operations in Seattle to resolve any forecast, planning and / or scheduling exceptions
  • Work closely with IMF management and all production staff to ensure timely delivery of final product
  • Manage the activities of the materials staff from receipt through QA release of all purchased goods and services.
  • Create, review, approve, and/or implement Standard Operating Procedures as required.
  • Maintain and monitor warehouse inventory levels.
  • Support the improvement of business processes including, purchasing, testing, release and finance
  • Develop, document, report on a timely basis various performance metrics and project reporting.
  • Create, track and manage project budgets, timelines, tasks, responsibilities and activities to meet Dendreon’s customer expectations
  • Identify and track metrics for monitoring manufacturing and process performance and/or consistency
  • Manage training programs for new and existing manufacturing operations associates, coordinators, and supervisors
Qualifications:
  • Bachelor’s degree in a scientific discipline or equivalent
  • Typically 7+ years related experience in cGMP/FDA regulated industry, Ideally with finite scheduling systems in a medium to high volume discrete order process manufacturing environment
  • Typically 3+ years leadership experience
  • Experience in Production Planning and Scheduling with cGMP manufacturing environment experience preferred
  • Experience in Six Sigma, Lean Manufacturing methodologies and application preferred
  • Knowledge of cGMP/FDA/IATA regulations
  • Proficient in MS Office applications and some exposure to ERP system
  • Proven leadership and team building abilities
  • Strong analytical, problem solving, and decision-making abilities
  • Excellent written and verbal communication skills
Working Conditions and Physical Requirements:
  • Ability to sit or stand for extended periods of time
  • Intermittent walking to gain access to work areas
  • Finger dexterity sufficient to use a computer and to complete paperwork activities
  • Vision sufficient to use a computer, to read written materials and to complete paperwork activities;
  • Hearing sufficient to communicate with individuals by telephone and in person
  • Ability to lift up to 25 pounds. Limited exposure to (2ºC - 8ºC); (-20ºC); (-75ºC); (-196ºC) areas.
  • Must have the ability to work around laboratories, manufacturing areas and equipment, and regularly lift 10 – 20 lbs and lift up to 50 lbs.
  • May be required to work alternate shifts
  • Ability to gown aseptically for work in Clean Room environments
  • Job performed in a lab, office, or utility (noisy) environment
  • Must have the ability to work around laboratories, manufacturing areas and equipment with exposure to blood, blood products or OPIM (other potentially infectious materials) while donning required personal protective materials.

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