Manager, Technical Operations - NY

Company: Curia
Location: Amityville
Posted on: March 20, 2023

Job Description:

Manager, Technical Operations

The Manager, Technical Operations assists in the oversight of total internal technical operations and completion of client project activities to support release of products for clinical trials and ensure the delivery of batch manufacture and documentation to GMP standards, in line with client project timelines. The job holder will also be required to liaise, guide and develop the wider production team to ensure continuous development and successful delivery of projects.

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.

Essential job duties

• Oversee the Technical Operations department
  
• Provide guidance and coordinate training for team members in all areas of Technical Operations
  
• Recommend and implement methods to increase the quality of products and/or services
  
• Develop batch records for client-specific formulation and filling operations
  
• Perform processing operations including equipment preparation, bulk product formulation, sterile filtration, and filling support to facilitate process design and internal technology transfer
  
• Identify and specify process specific equipment needed for client tech transfer and develop techniques and process parameters specific to the clients' product while maintaining critical product attributes
  
• Author and approve instructions for the operation of equipment and for detailing process flows in clean room facility
  
• Maintain 100% training on applicable curricula
  
• Understand and follow OSHA, HAZOP, and Curia procedures and guidelines when handling or disposing of hazardous materials and maintaining overall safety culture
  
• Perform hazardous waste handling operations in accordance with Curia procedures
  
• Create formulas, recipes, batches, and complete batch consumption in Oracle
  
  Supervisory responsibilities
  
  This position does have supervisory responsibilities.
  
  Education, experience, certification and licensures
  
  Required
  
• Bachelor's degree in Biology, Chemical Engineering or related field
  
• Minimum 8-10 years' experience in a cGMP and/or sterile manufacturing environment, including minimum 3 years in a management role
  
  Preferred
  
• Master's degree in Biology, Chemical Engineering or related field
  
• Experience with aseptic technique and clean room personnel flows
  
  Knowledge, skills and abilities
  
• Strong leadership skills
  
• Meticulous and highly organized
  
• Computer literate with good working knowledge of spreadsheet software (Visio or equivalent drawing programs a plus)
  
• Mastery of cGMPs in accordance with 21CFR210, and 21CFR211
  
• Mastery of the principles associated with aseptic filling technology (e.g. rotary piston/positive displacement pump, peristaltic pump systems)
  
• Ability to work with no supervision; interact well with clientele and interdepartmental teams
  
  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 sit; use hands to finger, handle, or feel; and talk or hear. The employee frequently is required to reach with hands and arms. The employee is occasionally required to stand; walk; climb or balance; and stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, and ability to adjust focus.
  
  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 has the potential of being exposed to fumes or airborne particles and toxic or caustic chemicals (wearing proper Personal Protective Equipment will be required in these situations). The employee is occasionally exposed to wet and/or humid conditions; moving mechanical parts; high, precarious places; outside weather conditions; and may be expected to work with electronic equipment (always being aware of one's environment and taking proper precautions is required). 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.
  
  #LI-DR1

Keywords: Curia, New Haven , Manager, Technical Operations - NY, Executive , Amityville, Connecticut