Director of Technical Manufacturing

Company: QIAGEN Gruppe
Location: Maryland
Posted on: August 6, 2022

Job Description:

At the heart of QIAGEN's business is a vision to make improvements in life possible.

We are on an exciting mission to make a real difference in science and healthcare. We are still the entrepreneurial company we started out as and have today achieved a size where we can bring our full power to many initiatives and to our presence across the globe. -
Our most valuable asset are our employees - more than 5000 in over 35 locations around the world. Our ambition is to ensure we have outstanding and passionate people working in the best teams and we are constantly looking for new talent to join us.
There are few players who have shaped the world of modern science and healthcare as much as QIAGEN, and we have only just started.
If you are looking to advance your career, are seeking new challenges and opportunities, enjoy working in dynamic and international, diverse teams and want to make a real impact on people's lives, then QIAGEN is where you need to be.

Join us. At QIAGEN, you make a difference every day. Position Description The Director of Upstream Manufacturing will be responsible for directing all of the upstream manufacturing and technical operations activities within a cGMP manufacturing facility. Ensures that production schedule is carried out efficiently and effectively while meeting relevant government regulations and international quality standards (i.e.; FDA, ISO, OSHA). This position is primarily responsible for representing manufacturing in cost analyses, R&D product transfer activities, new acquisition integrations and complaint resolution and therefore needs to be able to manage peers as well as direct reports in order to obtain favorable results. This position will also serve as the deputy site lead as required. MAIN TASKS (PRIMARY RESPONSIBILITES) OF THE POSITION: - Direct all activities within the manufacturing and technical operations teams.

- Responsible for decision making, which can have significant material impact on corporate product quality, corporate product cost impacting gross margin, and product availability to the marketplace.

- Direct the managers, supervisors and associates within the areas of responsibility. Mentor and foster the professional development of lead personnel within the organization.

- Represent upstream reagent manufacturing and technical ops in product transfer activities and participate in strategic decision making regarding new products, improvements to products, establishing and validating test methods and product specifications.

- Ensure SAP database pertaining to all areas of operation is properly maintained. Responsible for variance review and cost analyses.

- Implement process improvements and system changes to improve efficiency, product quality and regulatory compliance.

- Responsible for assessing core operational areas then developing and implementing optimized manufacturing processes that will provide more process robustness through improved reliability.

- Responsible for identifying areas for process improvements and redesign to include Life Cycle management for Germantown processes and products. - Responsible to set operational department strategy and provide critical input to site and regional strategy

- Perform trouble shooting as needed by designing experiments and analyzing data.

- Identify, draft and oversee execution of process validations where needed.

- Create / review / approve new production documentation for all areas of responsibility including labeling.

- Responsible for participating in audits as a key manufacturing representative.

- Ensure the laboratories are maintained in accordance with regulations and the production schedule is met in a timely manner with high quality results (low production costs, low backorder levels and high levels of efficiency and product quality. - -Technical f amiliarity with Immunological and molecular assays such as ELISA, PCR, and lateral flow devices SUPERVISORY RESPONSIBILITIES: - Responsible for managing a group of Managers and employees who have numerous areas of responsibilities for assuring continuous production). Position Requirements - MS or PhD degree (in Biological Sciences) plus minimum 7-10 years relevant manufacturing operations related laboratory experience in a managerial role. - Biology background experience preferred. GMP/diagnostic experience desirable. - Strong knowledge of areas that influence manufacturing costs. Understand what influences operational efficiencies and how to improve upon them. - Current knowledge of industry regulations and quality standards (cGMP, ISO).

- Proficient in MS Office applications - Word, Excel, Access, PowerPoint - Command of the spoken and written English language is required. Must be articulate and able to communicate effectively with employees at all levels of the organization. Must be able to write and review complex technical documents. - Excellent math skills including basic statistics are required. - Must be able to exercise sound judgment for significant decision making responsibilities, particularly in absence of the Senior Director of Operations and Site Head. - - Must be able to prioritize responsibilities in a multi-tasking environment. - What we offer At the heart of QIAGEN are our people who drive our success. We act with passion, always challenging the status quo to drive innovation and continuous improvement. We inspire with our leadership and make an impact with our actions. We create a collaborative, safe and engaging workplace which forms the basis for high performing individuals and teams. We drive accountability and entrepreneurial decision-making and want you to excel your growth and shape the future of QIAGEN.

QIAGEN is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, and medical conditions related to pregnancy, childbirth, or breastfeeding), sex stereotyping (including but not limited to assumptions about a person's appearance or behavior, gender roles, gender expression, or gender identity), gender, gender identity, gender expression, national origin, age, mental or physical disability, ancestry, medical condition, marital status, military or veteran status, citizenship status, sexual orientation, genetic information, or any other status protected by applicable law.

Keywords: QIAGEN Gruppe, Albany , Director of Technical Manufacturing, Executive , Maryland, New York