|
Working at Quanterix
Current Openings
|
 |
Head of Reagent Manufacturing & QC
Job Code: M–101
Description:
The position is a key role responsible for developing operations
for manufacturing and QC of reagents and kits (“raw materials
in to kits out”) that will be sold with the company’s
single molecule instrument into the life science and in vitro
diagnostics (IVD) markets. We seek an experienced individual
with a track record of managing manufacturing operations through
early stage growth. You will work closely with the company’s
R&D team to ensure successful process transfer and scale–up for
manufacturing, and to assist in product improvement. You will
interact closely with suppliers, the assay development team, and the
marketing team to ensure the production and packaging of high quality
products. You will be responsible for building a world–class
manufacturing organization from the ground up. You will maintain the
scientific integrity of the department, ensure the group’s high
morale and productivity, develop appropriate competencies, and manage
the department in a cost effective manner, meeting the financial
objectives set for the department. The position will involved the
following major activities:
- Build and manage the reagent manufacturing team, consisting
of technical staff and production employees.
- General oversight of the company’s reagent supply chain,
reagent manufacturing operations, and QC; development and
implementation of process controls, monitoring and continuous
improvement of reagent manufacturing processes and supporting
R&D requirements.
- Specific supply chain responsibilities include supplier
selection, qualification and management, inventory control,
purchasing, receiving and distribution.
- Specific manufacturing responsibilities include process/test
method validation, demand planning, scheduling, ordering and
inventory, reagent and standards manufacturing,
filling/labeling, kit packing, and shipping.
- Specific QC responsibilities include in–process QC and
final quality control method development and testing, quality
engineering within the organization and across the supplier
base for reagents, consumable and disposable components.
Responsibilities also include development of incoming QC
methods for materials used in manufacturing processes and products.
- This position requires hands on, management level experience
with both in–house and outsourced manufacturing environments;
strong process engineering background and thorough knowledge
of quality systems (cGMP and ISO:13485) and regulations (FDA
and IVDD) relating to medical diagnostic product manufacturing.
This position will work with Quality Assurance to establish
manufacturing policies, procedures and supporting quality infrastructure.
- Provides inspiring leadership for the reagent manufacturing
team, maintaining a high morale and teamwork in a fast–paced,
entrepreneurial, goal–oriented culture.
- Maintains close collaborations with other key functions involved
in the product development cycle – Research,
Assay Development, Engineering, and Marketing.
Requirements:
We are seeking candidates who share our Mission, Vision and Values and have the following credentials:
- Education: BS/MS/PhD in scientific discipline relevant to reagent manufacturing
- Experience:
- 5 to 7 years of related cGMP/FDA regulated industry experience.
- 3 to 5 years of managing supervisory personnel and contribution
towards the development of manufacturing strategies.
- Demonstrated knowledge of cGMP/ICH/FDA Regulations.
- Experience with department budget planning, management and reconciliation.
- Technically knowledgeable concerning manufacturing operations, planning
and scheduling, materials management, subcontracting, ERP, material flows,
and lean manufacturing principles.
- Communication: Must possess strong communication skills and
show the capability for independent planning of complex operations in a
regulated environment. Demonstrated ability to supervise and mentor teams
and guide them to achieve manufacturing goals. Effective presentation skills
and a comfort level with both the group as well as senior management.
Will also participate in writing area process and procedure documents.
- Management: Demonstrated ability to manage a technical
staff of more than 4 members. Able to work within a multi–disciplined
department. Able to manage budget, personnel, safety and facilities.
Qualified candidates should email their resume to hr@quanterix.com
[ back to Current Openings ]
|
