The Director, Manufacturing 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 (fill/finish, inspection) manufacturing process, project management, continuous improvement, change management, manufacturing investigations/corrective actions, participation in business reviews, and support of regulatory and client audits. 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.
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 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 (batch records) and “first time right” performance goals.
Responsible for administration of department budget to include forecasting resources for future periods.
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.
Education and Experience
Bachelor’s degree required (Engineering or Science related preferred).
8-12 years of related experience required.
Prior pharmaceutical experience, CMO or CDMO experience required.
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.
Expert knowledge of review/approving manufacturing investigations ensuring they are completed in a timely manner with appropriate root cause analysis and effective corrective/preventive action identified required.
Expert Knowledge of supporting the development of new or revised manufacturing instructions preferred.
Knowledge of operational procedures for equipment preparation, formulation, filing, capping and lyophilization activities within their respective cGMP guidance/procedures required.
Knowledge of leading manufacturing teams to maintain adherence to a demanding production schedule required.
Directly leads team of 1-2 direct reports.
Indirectly leads team of approximately 30.
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.
Up to 5% domestic travel
What We Offer You:
Competitive salary with career advancement opportunities
Profit sharing bonus plan
Medical, dental and vision coverage from day one
401(k) with company match
Company paid vacation, holiday and sick-leave
Voluntary benefits including short & long term disability, life, accident, critical illness insurances
Diversity and Inclusion:
Alcami values diversity and we are committed to creating an inclusive environment for all employees. All employment decisions are based on business needs, job requirements and individual qualifications, without regard to race, color, religion, sex, pregnancy, age, national origin, physical or mental disability, past or present military service, marital status, gender identification or expression, medical condition (including genetic characteristics) or any other protected characteristic as established by law.