Production Apprentice Supervisor

Employer
Bachem
Location
Torrance, CA, US
Posted
Nov 11, 2020
Ref
631841801
Hotbed
Biotech Beach
Required Education
Masters Degree/MBA
Position Type
Full time
The Production Apprentice Supervisor will assist the Production Manager in ensuring that all resources are assigned skillfully and efficiently for the manufacture of pharmaceutical products while meeting timelines, quality, and quantity. Responsibilities will include supervising a team of Chemists, Technicians and Apprentices within the Production Managers team. This role oversees those who are enrolled in the apprenticeship program and coordinates activities related to the program. He/she will train and supervise all employees under their shift, schedule shifts and coordinate production processes. He/she will be in charge of either the early/late shift operations to ensure safe, compliant and efficient function of the manufacturing plant. He/she will be responsible for enforcing health and safety policies and procedures, investigating, and reporting all accidents and incidents to the site management team. He/she must have the ability to make quick decisions and set priorities in the absence of the manager. This position will require a broad understanding of the manufacturing processes, equipment, utilities, GMP guidelines and flow of materials of the entire process. He/she will also be deputized to act on behalf of the Senior Director, Director, Assistant Director or Manager at Production meetings to provide input and feedback when necessary.

Your Tasks:

  • Manage a team of Production Chemists and Technicians for API Manufacturing as well as assist the manager in supervising a team of Chemist and Technicians responsible for manufacturing
  • Supervise or if needed execute all manufacturing stages which include but are not limited to: synthesis, cleavage, cyclization, conjugation, purification, reconstitution, lyophilization and in-process analytics
  • Responsible for managing the early/late shifts and ensuring safe, compliant and efficient functions of the department/organization
  • Coordinate the training schedule for the apprentices
  • Makes sure the apprentices receive all required training both onsite and off (RTI)
  • Ensures their time with the SME (OJT) is coordinated so as not to negatively impact production
  • Conducts all general overview training (nonspecific to PMO and peptides)
  • Conducts HSE enhanced training
  • Responsible for making sure team of Production Operators are in compliance with cGMP guidelines
  • Make sure all team members are trained on new revisions of applicable documents (BPR, SOPs etc.)
  • Supervise or if needed execute in-process analysis in all manufacturing stages
  • Assign tasks for team members and follow up on completion
  • Support the team with the necessary resources to ensure efficient and safe manufacturing operations
  • Comply with SOP's, BPR's and cGMP guidelines in all aspects of the work performed
  • Write technical reports, SOPs, BPRs, initiate process deviations, CAPA's and investigations
  • Adhere to manufacturing schedules and timelines
  • Propose technical and chemical improvements of the manufacturing process
  • Track and trend data for commercial processes to monitor that the process is in a state of control
  • Give presentations when necessary to share data, information, investigation findings etc. to the appropriate stake holders
  • Ensure that written procedures (SOP, BPR) and cGMP guidelines are followed and are up to date
  • Review and complete cGMP documentation
  • Ensure efficient collaboration between Production department and other supporting departments such as Operations, Logistics, QC, and QA
  • Train Production team members to the required standard of operation and evaluate their performances
  • Review and approve SOPs, BPR, process deviation and investigation once needed
  • Ensure safe, efficient and conscious use of the instruments, raw materials and other resources
  • Ensure manufacturing and personnel safety and security in the workplace
  • Ensure the production area is in continuous state of cGMP compliance at all times
  • Assist in the training and evaluation of new hires to the required standards of performance


Your Profile:

  • Master's Degree in Organic Chemistry, Biochemistry or the equivalent
  • Bachelor Degree in Organic Chemistry, Biochemistry or the equivalent and a minimum of 4 years of experience in Pharmaceutical Production
  • Working experience in cGMP manufacturing and the related documentation standards, including safety, health and compliance regulations as specified by federal, state, and local governments
  • Thorough understanding of all manufacturing stages and in-process analytical methods
  • Familiar with scientific, manufacturing equipments and utilities including but not limited to production
  • Knowledge of the chemical composition, structure, and properties of substances and of the chemical processes and transformations that they undergo. This includes uses of chemicals and their interactions, danger signs, production techniques, and disposal methods. Knowledge of solvent, waste and materials flow is required.
  • Routinely work with hazardous materials and manage hazardous waste in a satellite accumulation area.
  • Ability to work late shifts on a continuous basis and be flexible of working hours based on business needs, may include some nights and occasional weekends
  • Ability to work independently and manage one's time
  • Ability to manage a production team, set priorities and follow through on commitments
  • Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment
  • Ability to communicate in a proactive, and solution-focused manner, including keeping management aware of potential issues
  • Detail oriented with the ability to troubleshoot and resolve problems
  • Previous leadership experience
  • Excellent written and oral communication skills
  • Advanced Computer knowledge, including Microsoft Office applications


Preferred:

  • Experience in Training and Coaching
  • Experience in the API manufacturing
  • Experience as a Peptide or Oligonucleotide chemist
  • Proficient with all Peptide or Oligonucleotide manufacturing stages
  • Experience with Manufacturing Equipment such as reactors, prep. HPLC or lyophilizers on a commercial scale
  • ERP & training systems such as SAP and Master Controls


Nearest Major Market: Los Angeles