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Manager, Stability Storage

3 months ago

Durham, North Carolina, United States Cambrex Full time
Company Information

You Matter to Cambrex.

Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance, drug product, and analytical services across the entire drug lifecycle. With more than 40 years of experience and a growing team of over 2,000 professionals servicing global clients, Cambrex is a trusted partner in branded and generic markets for API and dosage form development and manufacturing.

Your Work Matters.

At Cambrex, we strive to build a culture where all colleagues have the opportunity to:
engage in work that matters to our customers and the patients they serve learn new skills and enjoy new experiences in an engaging and safe environment strengthen connections with coworkers and the community
We're committed to attracting and nurturing a passionate team of valued professionals in our fast-paced and growing company. We offer a competitive benefits package that includes healthcare, life insurance, planning for retirement, and more

Your Future Matters.

Known for our customer-focused scientific and manufacturing excellence, as well as our strong commitment to quality and safety, we offer a range of career and growth opportunities across our global network of locations. Together with our customers, we aim to improve the quality of life for patients around the world. Start a career where You Matter by applying today

Job Overview

Our Stability Storage facility is seeking a motivated manager to oversee a rapidly growing business unit. The person will manage a core-team focused on supporting a wide range of pharmaceutical storage programs.

This role is focused on managing the facility and team, with a priority for stability storage. The facility may also support the reference standard programs and method validations as needed. The person's primary responsibilities will include overseeing and planning capacity requirements for both headcount and facility, scheduling project workflows, providing technical guidance, and ensuring right-first time is given utmost priority on site. The leader will support other analytical core-teams to ensure a seamless transfer of knowledge.

This role will interact with clients and is responsible for successfully meeting client and departmental objectives in a timely manner.

Responsibilities

• Lead a Stability Storage-oriented core-team managing critical stability programs.

• Represents the department in meetings, collaborates and cooperates to achieve cross-functional improvements and business goals

• Ensure the facility is kept clean and equipment and maintenance schedules are maintained as specified by QMS.

• Assist with development, optimization and validation of new equipment

• Supports creations of departmental systems and fosters a culture of continuous improvement focused on value to the customer

• Cost control and commercial contract management.

• Annual budget preparation with support from senior management.

• Supports team to ensure proper management of the stability storage samples.

• Manages the day-to-day operations for assigned area.

• Works closely with site trainers to ensure all staff members are fully trained.

• Participates in and supports client visits, audits and inquiries to ensure complete fulfilment of requests and interests.

• Supports Recruitment, training, and retention of staff for the effective process of departmental operations.

• Provides technical guidance for troubleshooting and investigating simple to complex issues in area of expertise.

• Effectively resolves quality issues and concerns in a timely manner.

• Creates strong and effective relationships with clients.

Qualifications/Skills

• Strong technical skills for storage stability management

• Good business acumen with basic understanding of P&L and budget preparation.

• Strong understanding of company SOPs, and regulatory guidance documents.

• Strong knowledge of safety procedures and quality compliance for assigned area

• Strong knowledge of cGMP requirements.

• Experience with client audits is a plus.

• Strong understanding of basic lab techniques

• Strong knowledge of FDA, EU and ICH requirements and implementation for GLP and GMP in the pharmaceutical industry.

• If applicable, experience with compliance for drug substance and drug product.

• Experience with regulatory agency inspections of GXP facilities.

• Experience working with CDMOs.

• Flexible mindset to be able to learn and troubleshoot new techniques

• Must be able to schedule time and be organized

• Must have strong operational knowledge of instrumentation used to test small molecule pharmaceuticals including drug substances and drug product

• Ability to handle multiple priorities and projects concurrently

• Demonstrated accountability with prior positions

• Ability to adhere to a strict attendance policy

• Excellent verbal and written communication and analytical skill with a strong attention to detail

• Excellent analytical and problem-solving skills, with the ability to think strategically.

• Strong understanding of applicable GMP/ICH requirements

• Passionate about quality of work while remaining an inclusive team member, and technical driver

• Preference to those that demonstrate a winning attitude, cultural driver, great organizational skills, and attention to detail

• Strong attention to detail, as well as time and resource management.

• Strong personnel and professional integrity and trustworthiness with strong work ethics and the ability to work independently with some direction.

• Promote a safe environment for work.

• Comply with the general policy of the company.

• High level of personnel and professional integrity and trustworthiness with strong work ethics and the ability to work independently with minimal direction.

• Ability to develop and manage a high-performance team focused on quality, accountability and meeting and exceeding expectations.

Education, Experience & Licensing Requirements

BS or BA with at least 10 years laboratory experience in a stability Storage environment and 3+ years management experience is preferred with a focus in stability storage or similar.
Supervision Received: General Supervision

Exercises independent judgment in developing methods, techniques, and evaluation criteria for obtaining results. Acts independently to determine methods and procedures on new assignments. May seek management direction for problems of diverse and/or complex scope .

Travel: 5 - 10%

Physical Demands:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee may be required to use hands to finger, handle, or feel and to reach with hands and arms. The employee is required to talk and hear. The employee is frequently required to stand, walk and sit. The employee may be occasionally required to climb or balance. The employee may be required to regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, and peripheral vision.

Environment and Protective Equipment:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee may be occasionally exposed to moving mechanical parts, high precarious places and vibration. The noise level in the work environment is usually quiet. The employee may be required to gain access to lab, manufacturing or clinical areas for inspections or work discussions. The employee is required to wear the appropriate personal protective equipment to perform the job duties. Such personal protective equipment may include but is not limited to: safety eyewear, various types of respirators/breathing apparatus, lab coats, gloves, etc.

All requirements are subject to possible modifications to reasonably accommodate individuals with disabilities. Cambrex Corporation is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, sex (including pregnancy, sexual orientation, or gender identity), ancestry, national origin, place of birth, age, marital status, disability/handicap, genetic information, veteran status, or other characteristics protected by federal, state, and/or local law.