|at ( view profile)|
|Date Posted||July 24, 2019|
Contract GMP Manufacturing
|Address||W132N10550 Grant Drive|
The Technical Manager is accountable for driving results in a fast-paced environment by directing the development team activities. The Technical Manager is responsible for managing a cross functional team (chemistry development, analytical development and process engineering) to ensure successful process development and design for the introduction of new API molecules into the Germantown facility. The Technical Manager is accountable for the creation of a sound process control strategy by leveraging the technical knowledge and talents of their team, as well as facilitating the intra-team communication, coordination with external departments (e.g. production, PMO, EH&S, QC and QA), and supporting and delivering technical communication with customers. The Technical manager is ultimately accountable for the quality and timeliness of the technical package that is delivered from the development team, fostering a culture of innovation and right-first-time design to add value to our customer’s products and processes.The position requires superior leadership behaviors aligned with the Alcami core competencies and non-negotiables, as well as expertise in the functional competencies included in this position profile.
- Direct Supervision of the required Process R&D, Analytical R&D, and Process Engineering functions of their development team to ensure the development of a strong control strategy for successful production of API batches.
- Is accountable for the quality of the scientific content of project execution, communication, and documentation.
- Participates in face-to-face and teleconference meetings with the customer.
- Ensures execution of standard development work and that the required documentation (R&D reports, production reports, batch records, deviations, flow schemes,etc.) is generated and reviewed. Delegates if applicable and checks the contents for correctness.
- Ensures readiness for production through the coordination and on time delivery of the required information and materials for the production campaign.
- Ensures that production campaigns are supported and when needed supervised by the technical team.
- Is the primary contact for customers and auditors pertaining to the scientific aspects of projects.
- If applicable, supports technical transfer to the customer.
- Contributes to project evaluations.
- 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 (Chemistry, Pharmaceutical Sciences, and Engineering) required
- Master’s or Doctorate Degree preferred.
- 5 - 10 years of related experience required; 10+ years preferred.
- Prior pharmaceutical experience required; prior CDMO experience preferred.
- 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.
- Experience with project management, process chemistry, GMP and EHS guidelines.
- Capable of independently judging the scientific aspects of and solving the problems in, projects. Also capable of preparing and leading a project work-plan.
- Capable of leading cross-functional teams.
- Directly leads team of approximately 7 - 10 direct reports.
- Participates in the hiring process of new 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
- Applies job skills and company policies and SOPs to complete a broad range of difficult tasks.
- Uses professional concepts and critical thinking to solve complex problems.
- Receives minimal instruction on day-to-day work, general instructions on new assignments.
- Independently determines methods and procedures, including assignments and the work of others.
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