Supervisor, Compendial Testing , CDMO

At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise and proven regulatory track record.

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Job Summary

The Supervisor, Compendial Testing supervises and coordinates the activities of the assigned operation area and provides technical leadership for the assigned operations area. Expected to coach, train, and develop skills of the subordinate staff. The Supervisor, Compendial Testing will interact with clients and manufacturing and is responsible for successfully meeting client and departmental objectives in a timely manner.

On-Site Expectations

• 100% on-site position.
• 1st Shift: Monday - Friday, 8:30am - 5:30pm.

Responsibilities

• Supervises the day-to-day operations for assigned area with raw materials, packaging components and utilities (water and gas) testing using USP/EP/JP/ACS/FCC in a fast paced CDMO environment.
• Ensures all staff members are fully trained.
• Participates in and supports client visits, audits, and inquiries to ensure complete fulfillment of requests and interests.
• Recruits, trains, develops, and retains staff for the effective process of departmental operations.
• Provides technical guidance for troubleshooting and investigating simple to moderately complex issues in the area of expertise.
• Applies statistical analysis for interpretation of project data.
• Ensures all cGxP data generated for projects are managed and evaluated as described in relevant internal procedures and regulatory requirements.
• Effectively resolve related lab/quality issues and concerns in a timely manner.
• Enforces all laboratory safety, security, and housekeeping policies and procedures.
• Actively contributes to the preparation and coordination of internal audits and regulatory inspections.
• Creates strong and effective relationships with clients.
• Maintains a high level of professional and technical expertise through familiarity with scientific literature, conference attendance, and participation in training courses.
• Other duties as assigned.

Qualifications

• Requires a life science degree and 5+ years of relevant operations experience within the pharmaceutical industry testing raw material required. Chemistry degree preferred.
• Prior CDMO experience required.
• May be new to supervising staff but should have some experience managing projects and/or taking lead roles.

Knowledge, Skills, and Abilities

• Ability to manage multiple priorities in a fast paced CDMO environment.
• Good technical skills for area managing such as Titrations, KF, TLC and wet chemistry techniques.
• Strong understanding of company SOPs and regulatory guidance documents.
• Strong knowledge of safety procedures and quality compliance for assigned area.
• Good knowledge of cGMP requirements.
• Experience with USP/EP/JP/ACS/FCC required. 
• Conduct thorough OOS/ OOT investigations and implement appropriate CAPAs. 
• Experience with client audits.
• Good understanding of basic lab techniques.
• Proven ability to work with site Quality and Operation teams to build and standardize quality systems across sites.
• Good analytical and problem-solving skills with the ability to think strategically.
• Strong attention to detail as well as time and resource management.
• Strong personnel and professional integrity and trustworthiness with strong work ethics and the ability to work independently with some direction.
• Promote a safe environment for work.
• Comply with the general policy of the company.
• Communicate well orally both for internal customers and team members as well as external customers.
• Ability to write reports and business correspondences.
• Ability to listen and respond well to external customers, partners, and colleagues at all levels.
• Good team and interpersonal skills.
• Highly goal and result oriented.
• Tackles problems with enthusiasm and curiosity.
• Treats colleagues at all levels with respect.
• Good listening skills.

Travel Expectations

• Up to 5% travel is typical.

Physical Demands and Work Environment

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 may be required to use hands to finger, handle, or feel and to reach with hands and arms. The employee is required to talk and hear. The employee is frequently required to stand, walk and sit. The employee may be occasionally required to climb or balance. The employee may be required to 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, and peripheral vision.

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 may be occasionally exposed to moving mechanical parts, high precarious places and vibration. The noise level in the work environment is usually quiet. The employee may be required to gain access to lab, manufacturing or clinical areas for inspections or work discussions. The employee is required to wear the appropriate personal protective equipment to perform the job duties. Such personal protective equipment may include but is not limited to safety eyewear, various types of respirators/breathing apparatus, lab coats, gloves, etc.