Manager, Standards and Stability

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 Provides management of the Standard and Stability Department in accordance with organizational policies and applicable laws and guidance. Responsible for creating an environment that encourages compliant efficiency, developing and coaching technical staff to improve skills, ensuring high quality technical work, coordination, execution, and transfer of new processes while maintaining ongoing process performance. Understands and oversees a variety of chemical, biological, or microbiological analyses on products, raw materials, in-process materials, or stability samples in support of the company's Standard and Stability Program. Provides trouble shooting support and coordinates activities of personnel performing tasks required for standard and stability processes by performing the following duties.

Requirements

Bachelor’s Degree from a four 4-year college; or 5 years’ related experience and/or training; or equivalent combination of education and experience.
Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.
Ability to write reports, business correspondence, and procedure manuals.
Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the public.
Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations.
Ability to apply mathematical operations to tasks such as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, factor analysis, etc.
Ability to define problems, collect data, establish facts, and draw valid conclusions.
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, diagram or schedule form.
Results oriented approach to process performance
Strong leadership, delegation, verbal, and written communication skills
Ability to build relationships and influence and motivate others
Ability to achieve results through the positive direction of others
Coaching and mentoring skills
Technical expertise in the practices and technologies used in Standards and Stability, and the ability to use these skills in active projects
Advanced knowledge of chemical processing, lab equipment, and infrastructure
Analytical problem-solving skills, including the execution of LEAN operational excellence systems where applicable
Familiarity with investigation and incident response tools (e.g., cause mapping), CAPA management, and team-based problem resolution
Working knowledge of regulatory compliance issues in pharmaceutical manufacturing
Facilitation skills
Planning, implementation, and follow-up skills

Responsibilities

Maintains training of direct reports
Responsible for ensuring safe work practices
Performs laboratory investigations
Performs data review of laboratory data
Responsible for meeting timelines and client deliverables including stability pull dates, test dates, Test/review complete dates, and interim/final reports
Ensures the team completes generation and approval of protocols and reports in a timely manner
Ensures data integrity practices are followed
Responsible for the control, quality, and qualifications of standards
Establishes and maintains strong, transparent, and effective day-to-day working relationships between Operations, R&D, internal support, regulatory groups, and customers related to assigned duties. Acts as backup to Sr. manager/Associate Director of Quality Control as required
Actively collaborates with other centers of excellence and promotes cross-functionality where needed and/or where practical. Communicates with peers and management to ensure that Standards and Stability priorities are adequately defined and coordinated
Executes the efficient transition of processes from clients or development. May represent the department as part of the early process technical team, ensuring that method design and technology are compatible with roll-out to Standards and Stability
Leads programs to plan, execute, review, and improve department activities. Participates in the resolution of operational, process, equipment, and maintenance problems to prevent operational upsets
Directly or indirectly ensures that all process and documentation systems are maintained and executed to current expectations. Ensures that documentation is issued in a timely fashion and is completed within acceptable timelines. This includes final controls, change control, training information, safety procedures (e.g., shutdowns), and specialized operating procedures
Ensures that standard and stability processes are executed to the planned timing, to meet quality deliverables. Advises management when revisions of resources, schedules, and priorities are required
Provides input to annual operating budget and communicates issues with adherence within budget targets
Implements and maintains adherence to all company policies concerning environmental, health, safety, quality, and human resources
Develops and maintains department and site goals. Maintains and monitors department KPIs
Manages and directs the Standard and Stability Programs
Develops employees; planning, assigning, and directing work; meeting goals and performance standards; and driving continuous improvement
Coordinates operational staff and facilitates activities of technical (or other support) staff in the Standards and Stability areas. Acts as a single point of contact for implementation of a new process. Acts as backup when Sr. Manager/Associate Director is out. Contributes to annual spending and CAPEX forecasts and participates in strategic capability planning.
Management 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. Provides direct supervision and conducts performance reviews on reporting staff.
Every individual is personally responsible for the safety and environmental aspects of his or her activities in the workplace. Each employee is expected to perform their job duties in a safe manner utilizing all their knowledge, training, ability, and experience.
Corden Pharma Colorado (CPC) is a manufacturer of a variety of pharmaceutical products. In following Current Good Manufacturing Practices (cGMP), Corden Pharma Colorado manufactures in accordance with the US Food and Drug Administration (FDA), International Council for Harmonisation Q7 (ICH), and other global regulations as applicable. This is critical as it is our mission to not place patients at risk due to inadequate safety, quality, or efficacy. CPC’s Quality Management System, which incorporates cGMP, is designed to deliver this quality objective. Attainment is produced through the requisite participation and commitment of all staff across departments and at all levels within the company.
Adherence to clearly defined procedures, in compliance with the principles of cGMP, is required when performing operations across Corden Pharma Colorado.
Responsible for training of new technicians and analysts
Confers with scientists or engineers to conduct analyses, interpret test results, or develop nonstandard tests
Interprets and evaluates the analyses of stability and finished good samples, in terms of accuracy and precision
Generates and reviews required stability and standard protocol and reports
Supports development of new methods, qualification, and revises current methods in support of current processes and technology
Responsible for properly managing the generation and accumulation of hazardous and non-hazardous waste

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