Process Project Lead

Corden Pharma Colorado

About The Position

CordenPharma is a leading full-service Contract Development and Manufacturing Organization (CDMO) specializing in active pharmaceutical ingredients (APIs), excipients, drug products (DPs), and packaging. With around 3,000 employees worldwide, we help pharmaceutical, and biotech companies manufacture medicines with the ultimate goal of improving people’s lives. Our network, spanning Europe and the U.S., provides flexible and specialized solutions across six technology platforms: Peptides, Lipids & Carbohydrates, Injectables, Highly Potent & Oncology, Small Molecules, and Oligonucleotides. We strive for excellence in supporting this network and are committed to delivering the highest quality products for patient well-being. Our People Vision We strive for excellence. We share our passion. Together, we make a difference in patients' lives. SUMMARY Responsible for providing group-level leadership for the Process Chemistry Department to provide results in order to meet business needs. Guides, directs, and reviews work done by Process Chemists to support the development of new pharmaceutical processes. The Process Project Lead ensures the technical feasibility, economic competitiveness, and overall robustness of new and existing processes. The Process Project Lead also supports and troubleshoots investigations into processes in non-commercial manufacturing. The Process Project Lead’s further responsibilities include training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; and addressing complaints and resolving problems. The incumbent is responsible for creating an environment that encourages technical excellence, developing, and coaching the group to improve skills, while ensuring high quality technical work.

Requirements

Five years of practical work experience in API Pharmaceutical Process Development, including all aspects of Process Chemistry from scale-up and process safety considerations to the API Regulatory approval process.
Exhibits expert abilities in the design of chemical processes, and in the implementation of common unit operations.
The ability to formulate and articulate a cohesive strategy for process development, including its regulatory aspects.
Advanced communication skills are necessary to interrelate with external customers and other departments within the company structure.
PhD in Chemistry or equivalent combination of education and work experience.
The ability to write reports, proposals, contracts, business correspondence, and procedure manuals.
Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
Ability to calculate figures and amounts such as proportions, percentages, area, circumference, and volume.
Ability to apply concepts of basic algebra and geometry.
Ability to convert units of measurement.
The ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
Ability to interpret a variety of instructions furnished in written, oral, diagrammatic, or schedule form.
Communication – oral and written
Administration - able to organize group to achieve group goals and objectives
Analytical Methodologies – HPLC/UPLC, GC, IR, UV, IC, NMR
Analytical Instrumentation – comfortable with the use of common analytical techniques
Process Instrumentation – understanding common development tools such as pressure vessels, large-scale lab equipment (20-50 L), optical analysis probes, parallel process development equipment, and the like
Regulatory Compliance – excellent working knowledge of ICH guidelines/USP/EP/JP, SME for inspections
Quality Compliance – performing and supporting investigations, determinations of root cause and preventative measures

Responsibilities

Guides, directs, and reviews work done by their group to ensure an exceptional level of project performance
Responsible and accountable for all aspects of project performance within their group. Including meeting technical, timeline, and budgetary objectives, as well as Client satisfaction
Ensures experimental plans are designed to ensure project objectives are met
Takes the lead in customers and interdepartmental communications, or delegates to sufficiently trained and competent group members
Enforces compliant working practices including completion of all required training, attendance at scheduled safety meetings, and performance of safe operating practices in the labs, production areas, and office areas
Manages performance of group members according to Corden standards and job descriptions
Is involved in professional development, recruiting, hiring, and promotions for the members of the group
Applies principles of Continuous Improvement to ensure work processes and business process are meeting business and client needs
Supervises and directs the group directly in cooperation with department manager and project managers.
Responsible for effective communication within the group, the department, and externally to the site, other sites, and external customers as appropriate.
Supervisory responsibilities include daily leadership of team; training and development; interviewing and hiring; managing time and attendance records; performance appraisals; rewarding and disciplining employees; and resolving daily problems and conflicts.
Every individual is personally responsible for the safety and environmental aspects of their activities in the workplace.
Each employee is expected to perform their job duties in a safe manner utilizing all of their knowledge, training, ability, and experience.

Benefits

401(k) matching - Corden Pharma will contribute 100% of the first 6% - 100% vested after 2 years of service
Accident Plan
Critical Illness Insurance
Dental Insurance
Disability Insurance
Employee Assistance Program
Flexible Spending Account
Health Insurance PPO/HSA
Hospital Indemnity Plan
ID Theft Protection
Life Insurance
Paid Parental Leave
Tuition Reimbursement
Wellness Program
Vacation – Three Weeks 1st Year
Vision Insurance