Manufacturing Technician F/H

L'entreprise

HTL Biotechnology is a French biotech and a world leader in the development and responsible bioproduction of pharmaceutical-grade biopolymers. These biopolymers are used by healthcare companies for the development of treatments in various cutting-edge therapeutic areas such as ophthalmology, dermatology, medical aesthetics and rheumatology.

For over 30 years, HTL Biotechnology has been a driving force behind innovation in the sector, collaborating with research entities and biotech companies to address unmet medical needs (regenerative medicine, drug delivery, etc.) HTL Biotechnology recently reinforced its position as world leader in the development of pharmaceutical-grade biopolymers by acquiring, through its subsidiary HTL Biotechnology Innovation Inc (HTL BII – New Jersey), a recombinant protein platform whose most advanced product is recombinant human collagen type III (rhCOL3), within a world-class scientific research center.

To meet growing global needs for biopolymers, the company has also subsidiaries in Asia and is building in the United States, a neuromodulator production unit (HTL BMI – Massachusetts). Historically based in Javené (Brittany - France), the company brings together production, innovation, research and development, as well as quality activities on its site. HTL Biotechnology employs nearly 300 people worldwide.

Our ambition is to consolidate our global leadership and create value for our customers with four priorities:

• Premium positioning, by guaranteeing a high level of product quality and safety
• Innovation, by driving research in the biopolymers sector.
• International expansion, by placing production and R&D at the service of new markets and customers.
• Social responsibility, through which we aim to transform the biopolymer sector into a positive, sustainable force.

This position will be located in Canton MA, USA

Description du poste

Essential Duties & Responsibilities :

Manufacturing:

• Work in BLS2/BLS3 environment following CDC regulations and aseptic practices (understand and follow the security practices of the facility and the manufacturing process of regulated select agents and attend training courses on the specifics of the production process and working with highly potent active ingredients). 
• Perform manufacturing activities including but not limited to fermentation, purification and in compliance with CGMP regulations and company SOPs.
• Appropriately transfer or ship any hazardous material according to local and federal regulations.
• Manage production waste (treat, handle and dispose) as per HTL’s SOPs.
• Appropriately clean and maintain all equipment used in the manufacturing of the product.
• Maintain and update all equipment logbooks.

Operations Support:

• Perform periodic checks for the facility and equipment.
• Coordinate internally and with vendors for cleaning, calibration and system maintenance.
• Material management activities including but not limited to shipping, receiving and inventory management.
• Maintain inventory of supplies, raw materials and products in collaboration with the manufacturing team for timely execution of activities.

Compliance and Documentation:

• Write, maintain and update SOPs related to manufacturing and facility operations (batch records, work orders, etc.).
• Participate in internal audits and inspection.

Profil recherché

Experience, Skills & Knowledge :

• High School Diploma or GED equivalent required.
• Associate or bachelor’s degree in science, Chemistry, Biology, or similar degree required.
• strong background in pharmaceutical manufacturing and supporting facility operations, with a keen eye for detail and a commitment to maintaining high-quality standards (previous work in CGMP environment is preferred).
• Ability to work effectively with others in a team-oriented environment and independently when needed.
• Ability to adapt to changing priorities.
• Ability to work with precision and thoroughness/detail-oriented
• Ability to work with a strict safety manner
• Possesses good organizational, communication and technical writing skills.
• Proficiency in Microsoft office.

What we offer:

We believe in investing in our employees’ wellbeing and professional growth at HTL Biotechnology and are pleased to offer comprehensive benefits for the total health of our organization including:

·        Competitive compensation, including Bonus program

·        Retirement planning (5% 401k Matching)

·        Comprehensive benefit plans covering medical, dental, vision, life, and disability

·        Collaborative, transparent, and inclusive culture and activities

·        Winter Break (Company observed reset and recharge, final week of the year)

Details of these benefit plans will be provided if a candidate receives an offer of employment.

HTL Biotechnology is an equal opportunity employer. In accordance with anti-discrimination law, we prohibit discrimination and harassment of any type and afford equal employment opportunities to employees and applicants without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.

To learn more about HTL Biotechnology: http://htlbiotech.com/

LinkedIn: HTL Biotechnology

Réf: 880384c2-9b62-49f2-bcd0-8266bc51b391