Head of Reagent Manufacturing & QC Quanterix

Head of Reagent Manufacturing & QC
Job Code: M101

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 companys 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 companys R&D team to ensure successful process transfer and scaleup 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 worldclass manufacturing organization from the ground up. You will maintain the scientific integrity of the department, ensure the groups 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 companys 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 inprocess 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 inhouse 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 fastpaced, entrepreneurial, goaloriented 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 multidisciplined department. Able to manage budget, personnel, safety and facilities.

Location:	One Kendall Square Building 1400 Cambridge, MA 02139 United States