Production Supervisor BSD 31412 API 2

Your Responsibilities

The Production 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 and Technicians within the Production Managers team. 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 train and supervise all employees under their shift, schedule shifts and coordinate production processes. 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

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 equipment's 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 the API manufacturing

Experience as a Peptide or Oligonucleotide chemist

Proficient with all Peptide or Oligonucleotide manufacturing stages

We Offer

You will be part of a motivated team overseeing the entire development cycle of respective APIs. If you are

looking for a new challenge and want to join a motivated team in an internationally renowned company,

you should seize this opportunity.

Nearest Major Market: San Diego