Supervisor, Environmental Monitoring

Free Healthcare Option | Bonus Program | 401(k) with Match | College Loan Forgiveness
Core Values: Trustworthy, Relentless, Accountable, Collaborative, Customer-Focused, and Skilled

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.

Are you interested in joining our team?

Job Summary:

The Supervisor, Laboratory Operations is accountable for driving results in a fast-paced environment by providing operational leadership for the Charleston Environmental Monitoring (EM) group by developing and mentoring staff, interacting with manufacturing and quality, presenting ongoing trending data, keeping the EM group compliant with Annex 1 and delivering results through execution and technical guidance.

On-Site Expectations:

• 100% on-site position.
• 1st Shift: Monday - Friday, 8:00am - 5:00pm.
• Provide alternate/off-shift support in assisting with routine or non-routine environmental monitoring activities as required.

Responsibilities:

• Provide supervision and oversight of the QC Environmental Monitoring Technicians during the day-to-day activities, including any non-routine day-to-day activities (i.e. Media Fills, EM PQs) that may arise based on production needs.
• Coordinate environmental monitoring activities and assign job responsibilities to QC Environmental Monitoring Technicians.
• Perform technical training and mentor QC Environmental Monitoring Technicians.
• Provide shift support for QC Environmental Monitoring Technicians when non-routine events occur and escalate to management as required.
• Author and review Standard Operating Procedures, Work Instructions/Tools, and assist with development of the QC Environmental Monitoring Technician's Learning and Development Training.
• Facilitate development for all direct reports, including but is not limited to coaching/mentoring of QC Environmental Monitoring Technicians, establishing goals, and providing performance improvement and performance recognition feedback.
• Comply with and assist in implementing safety standards.
• Understands the science behind the approach in environmental monitoring.
• Leads investigations.
• Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
• Attracts, develops, and retains a high performing team to meet the current and evolving needs of the business through effective selection, training and development, coaching and mentoring and performance management.
• Other duties as assigned.

Qualifications:

• Bachelor's Degree in a scientific discipline and 2 years of relevant operations experience within the Pharmaceutical industry.
• May be new to supervising staff but should have some experience managing projects and/or taking lead roles.
• Previous experience working in a cGMP environment with in-depth knowledge of cGMP and other applicable regulatory requirements
• Previous experience within CMO, or CDMO preferred.

Knowledge, Skills, and Abilities:

• Demonstrated success and knowledge in developing and validating analytical methods.
• Excellent technical skills to understand laboratory processes, GMP, compendial and ICH guidelines.
• Proven ability to drive metrics and KPI's.
• Ability to successfully investigate and write laboratory investigations.
• Ability to communicate at all levels both verbally and written.
• Understanding of drug development regulatory requirements.
• Possesses a strong energy, resilience, and personal commitment to achieve successful results.
• Excellent verbal and written communications and presentation skills required.
• Proficiency with MODA, NuGenesis, and Microsoft Office (Word, Excel, PowerPoint) required.
• Directly leads team of approximately 5-8 direct reports across three shifts.
• Participates in the hiring process of other employees.
• Schedules and reviews the work of other employees.
• Ensures accuracy and relevance of assigned training curriculum.
• Drives timely completion of training for employees to meet regulatory requirements.
• Coaches, mentors and develops other employees.
• Prepares and delivers performance evaluations of other employees.
• Makes recommendation of disciplinary actions of other employees.

Travel Expectations:

• Up to 10% domestic travel.

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 is regularly required to use hands to finger, handle, or feel; reach with hands and arms; talk or hear and smell. The employee is frequently required to stand. The employee is occasionally required to walk; sit 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, depth perception and ability to adjust focus.

While performing the duties of this job, the employee is frequently exposed to moving mechanical parts and the risk of electrical shock, burn hazards and microbial contamination. The employee is occasionally exposed to fumes or airborne particles, toxic or caustic chemicals and vibration. The noise level in the work environment is usually moderate. The employee will be required to wear the appropriate personal protective equipment for specific job duties to be performed. Such personal protective equipment may include, but not limited to safety eyewear, various types of respirators/breathing apparatus, lab coats, full protective body coverings, various types of gloves, etc.

About Us:

Alcami is a contract development and manufacturing organization headquartered in North Carolina with over 40 years of experience advancing products through every stage of the development lifecycle. At Alcami, we are a team of dynamic, agile individuals committed to developing life-saving drugs around the world. A mindset of collaboration, innovation, responsiveness, accountability, and customer focus inspires us to be the most efficient, safe, and reliable choice for our customers and the patients they serve. In return, we offer challenging careers, professional growth, and the opportunity to be part of our skilled team with over 40 years of experience as champions that are dedicated, trustworthy, and relentless to advancing products through every stage of the development cycle. Alcami offers an extraordinary opportunity, a competitive salary, and an exceptional benefits package including medical, dental, vision, and prescription coverage, life, LTD, STD, 401(k) with match and immediate vesting, and tuition reimbursement / student loan forgiveness.

Diversity and Inclusion:

Alcami is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.