Position Summary

The Manager, Compounding and Visual Inspection is accountable for driving results in a fast-paced environment by leading manufacturing team in Drug Product Operations. This role will be the subject matter expert in the compounding and visual inspection area, ensuring clients’ products are manufactured and released succesfully in the manufacturing area. The ideal candidate will work with the Aseptic Manufacturing Manager, Commercial and Business Leaders in planning and executing manufacturing schedules and making recommendations to improve the manufactruing process. This role will be expected to stay abreast of the latest technology and how it may be used to keep Alcami at the top of the industry. The Manager, will lead a team of manufacturing technicians in transfer of the compounding process from scale up to manufacturing execution to ensure cGMP, guidance documents and standard operating procedures are understood and followed. This role must have working knowledge of visual inspection (pre-filled syringes, clear and lyo vials), tech transfers, scale-up, scale-down, equipment qualifications, and process improvements in cGMP manufacturing environment. The position requires superior leadership behaviors of the Alcami core competencies and non-negotiables, as well as expertise in functional competencies included in this position profile.

Essential Functions

• Plans and executes compounding of product to ensure successful filling operation.
• Ensures FDA/MHRA requirements on equipment and processes are met.
• Ensures regulatory (safety and compliance) inspection readiness in manufacturing organization.
• Leads the development and implementation policies that meet current and upcoming compliance and operational trends.
• Demonstrates strong customer interaction and presentation of technical recommendations.
• Pays specific attention to equipment operating practices and conditions to minimize equipment down time, lower maintenance costs, reduce time to run project and repeat of work.
• Demonstrates strong technical understanding of processing small and large molecule compounds, controlled substances and high potency compounds.
• Manages batch records, prepares technical reports, processes qualification and equipment configuration reporting.
• Prepares and carries out presentations related to the Company or project information.
• Provides significant input in budget process.
• Engages with business development and contract writing personnel to provide key support in project definition and costing.
• Ensures production schedules are met or expectations are proactively managed towards alternative solutions.
• Develops and implements key strategic polices and procedures.
• 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.

Educationand Experience

• Bachelor's degree in Engineering, Chemistry, or Life Sciences with 7+ years of industry related experience, including 2+ years of management experience.
• Experience as it relates below:
  • Basic understanding and application of chemistry principles (pH titration, solubility, stability) in manufacturing in the CDMO/CMO industry.
  • Technology transfer and scale up process.
  • Managing batch records, preparing and reviewing technical reports, process qualification and equipment configuration reporting.
  • Customer interaction and presentation of technical recommendations.
  • Defense of regulatory processes to appropriate regulatory agencies (i.e. FDA, etc.)

Alcami Non-Negotiables

• Consistently demonstrates honesty and integrity through personal example.
• Follows all safety policies and leads by example a safety first culture.
• Produces high quality work product with a focus on first time right.
• Complies with the company code of conduct and policies and regulatory standards.

Alcami Core Leadership Competencies

• Thinks strategically. Quickly identifies and acts on opportunities. Considers the downstream impact. Seeks to understand the why. Focuses on work that matters.
• Develops organization and others. Takes ownership to develop self and others. Seeks out new opportunities and experiences for continuous learning.
• Acts decisively. Makes and acts on decisions quickly. Makes decisions with the customer and their patients in mind. Meets commitments with a sense of urgency. Seeks ways to be more efficient.
• Drives performance. Holds self and others accountable. Delivers results first time right. Never settles for status quo. Willing to have tough conversations. Asks for feedback and takes action to improve.
• Passion for customers. Listens to understand. Asks the right questions. Gets to the heart of the matter and uses that insight to provide value.
• Works collaboratively. Seeks out the experience of others with the aim for better results. Open minded regardless where ideas originate. Flexible and easy to work with.

Functional Competencies

• Demonstrated knowledge and hands on experience in the area of responsibility.
• Excellent understanding of the theoretical background/fundamentals of the work.
• Outstanding capability of client management.
• Ability to plan and forecast the financial performance of the organization.
• Understands industry business trends as well as regulatory and technical trends.
• Ability to work effectively in a matrixed environment.
• Basic understanding of hiring and employment practices.
• Advanced problem-solving capabilities.
• Consistent attention to details.
• Superior leadership skills.
• Excellent time management and organization skills.
• Excellent communication and presentation skills.
• Ability to effectively multitask.
• Computer proficient.

Supervisory Responsibilities

• Directly or indirectly leads team of approximately 4 - 8 direct reports.
• Participates in the hiring process of other employees.
• Makes hiring decisions 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.

Decision Making and Supervision Required

• Uses professional concepts and critical thinking to solve complex problems.
• Independently determines methods and procedures, including assignments and the work of others.

Travel Requirements

• Up to 5% travel required.

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 sit. The employee is occasionally required to stand; walk 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 occasionally exposed to moving mechanical parts and vibration. The noise level in the work environment is usually very quiet.

Other Duties

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.