Posted in Other 30+ days ago.
Type: Full Time
Think Different. Do Different. Be Different.
Alcami is a world-class contract development and manufacturing organization (CDMO). We are a team of dynamic individuals committed to developing life-saving drugs around the world. A mindset of innovation, 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, accelerated professional growth and the opportunity to be part of something different.
Position Summary
The Supervisor, Laboratory Operations is accountable for driving results in a fast-paced environment by providing operational leadership for the Wilmington Development Services businesses by developing and mentoring staff, interacting with clients, presenting organizational capabilities, defining scope of work and delivering results through execution and technical guidance. 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
- Highly skilled in method development concepts with strong development strategies to produce robust, accurate, and reliable methods for a wide range of pharmaceutical dosage forms in a cGMP environment.
- Provides strong technical oversight for the onboarding of analytical methods (i.e. validation, transfer, verification) to ensure full compliance with regulatory, ICH, and compendia guidances.
- Writes/reviews complex scientific method development and validation protocols and reports.
- Oversees completion of analytical testing to support Manufacturing and stability testing in a cGMP environment.
- Maximizes equipment operating practices and conditions to minimize equipment down time, lower maintenance costs, reduce time to run project and repeat of work.
- Understands the theoretical basis of methods/experiments.
- Achieves results by solving problems of a diverse scope.
- Drives initiatives outside of standard work function.
- Leads and authors strong and thorough laboratory investigations
- Effectively communicates with clients and internal groups.
- Works with business development and contracts to assist in project definition and costing.
- 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 in Chemistry, Biochemistry or related scientific discipline, with a minimum of 6 years of experience in Pharmaceuticals; OR
- Master's Degree in a scientific discipline with a minimum of 2 years of experience preferred
- 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.
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 success and knowledge in work 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.
- Demonstrated success leading a best in class formulations team.
- Proven ability to create and operate a customer responsive organization.
- 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 Microsoft Office (Word, Excel, PowerPoint) required.
Supervisory Responsibilities
- Directly leads team.
- 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.
Travel Requirements
- Up to 10% 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.
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