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Curia Director, Production Operations Sign On Bonus Offered and Highly Competitive Starting Base Salary in Burlington, Massachusetts

Director, Production Operations

Curia provides global contract research and manufacturing services to the pharmaceutical and biotechnology industries.

The Director, Production Operations is responsible for overseeing the sanitation and preparation of the processing facilities, preparation of all components and equipment used in the sterile filling process, conduction of the sterile filling processes, decontamination of sterile filling equipment, the visual inspection of all filled units and the technical services team that support commercial production and technology transfer of clinical and commercial processes.

This role includes the management of assigned lines of manufacturing operations and personnel which encompasses planning, coordinating, and supervising manufacturing in accordance with delivery dates, customer specifications and established quality standards. The responsibilities for the Director, Production Operations includes overseeing Wash & Prep, Glass Prep, short-range production scheduling, sanitation, sterilization, sterile filling and visual inspection. This position is the primary contact for customer relations and interactions. This role is responsible for all aspects of product. The Director, Production Operations will be responsible for developing and implementing metrics to evaluate the performance of the manufacturing operations. The role is also responsible for the training and development of the aseptic filling team including management, hourly and supervisory personnel.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Supervisory responsibilities

This position does have supervisory responsibilities.

Essential job duties

  • Perform the usual duties of a Director, Production Operations such as developing and managing budget and performance objectives, scheduling, hiring, timecards, performance evaluation, termination, etc.

  • Supervise the employees and functions of the Production Operations areas in the preparation of equipment and components to be used in the filling process and the completion of the sterile filling process

  • Review and approve discrepancy reports to effect release of product

  • Lead, attend and participate in meetings that affect release of product and schedule planning

  • Work on projects to analyze and improve manufacturing process; writing SOPs and documenting project

  • Ensure proper training of staff and appropriate records of training have been kept

  • Directly and through staff ensure cleanliness of assigned areas, sanitation of clean rooms, sterilization of filling equipment, the wash and prep of filling equipment, the preparation of vials and ampoules, and the completion of the sterile filling process

  • Directly and through staff understand and implement safety procedures and cGMP

  • Responsible for the training and development of the supervisory staff

Education, experience, certification and licensures

Required

  • Bachelor’s degree in Engineering, Business, Manufacturing, Science, or related field

  • Minimum 12-15 years’ directly related experience in pharmaceutical industry, including 7 years in a leadership role

  • U.S. employees of Curia Global Inc. and its subsidiaries (a “Company”) must be fully vaccinated against the COVID-19 virus and provide the Company with proof of vaccination as a condition of their employment except for U.S. employees who request and qualify under applicable law for disability and religious accommodations from the COVID-19 vaccine mandate. An applicant who receives an offer of employment from the Company for a position as a U.S. employee will be required to provide proof of vaccination, or to request and receive a disability or religious accommodation that the applicant is entitled to under applicable law, before their first day of employment or any earlier or later deadline specified by the Company in the offer letter. The Company is an equal opportunity employer and provides employment opportunities and makes employment decisions without regards to an individual’s disability or religion or on any other basis prohibited by applicable law.

Knowledge, skills and abilities

  • Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals

  • Ability to apply basic math concepts

  • Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form

  • Proficient in the use of MS Word, Excel, Outlook and Access, as this individual will perform work within these systems on a routine basis

  • Excellent communication skills, both verbal and written

  • Ability to organize time in order to successfully manage multiple projects and priorities

  • Ability to read, understand, interpret and implement technical writing and instructions

  • Effective inter-personal relation skills, while maintaining the adaptability to achieve company goals

  • Verbally expresses ideas and facts in a clear, logical, concise and in accepted grammatical style

Physical requirements

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this Job, the employee is regularly required to talk or hear. The employee is frequently required to sit and use hands to finger, handle, or feel. The employee is occasionally required to stand; walk; reach with hands and arms; climb or balance and stoop, kneel, crouch, or crawl. The employee must regularly lift and /or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision and depth perception.

Work environment

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts; high, precarious places; fumes or airborne particles; toxic or caustic chemicals; risk of electrical shock; explosives; risk of radiation and vibration. The noise level in the work environment is usually moderate.

The above statements are intended to describe the general nature and level of work performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all job duties performed by the personnel as classified. Management reserves the right to revise or amend duties at any time.

Curia is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

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