Director, Manufacturing Sterile Operations

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 Director, Manufacturing Sterile Operations is accountable for driving results in a fast-paced environment by providing leadership to the site’s manufacturing function. Focus areas for the role include operational leadership, parenteral (Filling and Visual Inspection) manufacturing process, project management, continuous improvement, change management, manufacturing investigations/corrective actions, participation in business reviews, and support of regulatory and client audits.

On-Site Expectations

100% on-site position.
1st Shift: Monday - Friday, 8:00am - 5:00pm.

Responsibilities

Directs and leads the Manufacturing team to deliver on the schedule of four aseptic isolator fill lines and visual inspection to meet company and client demand.
Leads manufacturing and cross functional support teams with Lean Six Sigma / continuous improvement mindset and principals to achieve higher quality, compliance, and productivity goals.
Develops information and produces reports concerning scheduling, production goals, equipment and maintenance problems and other studies or reports as requested.
Provides manufacturing information by compiling, initiating, sorting, and analyzing production related records and data to key stakeholders within Alcami.
Ensures all manufacturing discrepancies are captured with appropriate documentation and then works collaboratively with appropriate personnel to facilitate client communication per quality agreements.
Accountable for accurate and timely completion of all department investigation reports and the effective and timely corrective/preventative action (CAPA) implementations and follow-up.
Accountable for the accurate and timely completion of all manufacturing processes and documentation (Manufacturing Batch Records and Quality Records) and "Right First Time" performance goals.
Responsible for setting strategic direction and administration of Manufacturing.
Responsible for budgets, forecast, and long-term planning and development of human and manufacturing resources.
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 required (Science or Engineering related preferred).
10+ years of CDMO or pharmaceutical experience required, 6+ years of management experience required.
Prior pharmaceutical experience in sterile aseptic filling and visual inspection is required; prior CDMO experience preferred.
Solid understanding of FDA and ANEX 1 aseptic guidelines and regulations.
Prior experience with final product release, major equipment validation, validation protocol review, process validation protocol review, 21 CFR Part 4/ISO 13485 and APRs preferred.

Knowledge, Skills, and Abilities

Strong knowledge of pharmaceutical regulatory requirements and cGMP required.
Knowledge of quality systems and processes, change control, CAPA and data integrity required.
Knowledge of aseptic processing of commercial or clinical parenteral products.
Have participated in /or lead regulator audits.
Excellent skills in leadership, coaching and influencing others, strategic planning, critical thinking and problem solving, root-cause analysis and written communication and presentation skills required.
Strong business acumen.
Good presentation skills.
Strong understanding of industry requirements, and regulatory guidance documents.
Strong knowledge of safety procedures and quality compliance.
Strong knowledge of cGMP requirements.
Strong experience with client audits.
Excellent analytical and problem-solving skill, 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.
Promote a safe environment for work.
Comply with the general policy of the company.
High level of personnel and professional integrity and trustworthiness with strong work ethics and the ability to work independently with minimal direction.
Develop and manage a high-performing team, focused on quality, accountability, meeting and exceeding expectations.
Communicate well orally both for internal customers and team members as well as external customers.
Write reports and business correspondence.
Listen and respond well to external customers, partners, and colleagues at all levels.
Highly goal and result oriented.
Prioritize tasks according to business objectives and can pursue several objectives simultaneously.
Works independently with a high degree of self-motivation.
Collaborates effectively with others cross functionally to accomplish goals.
Tackles problems with enthusiasm and curiosity.
Treats colleagues at all levels with respect.
Very effective listening skills with the ability to hear attentively and process information correctly.

Travel Expectations

Up to 10% travel expected.

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.

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.