Senior Manager (OT/CSV) - Professional Service Operations
TITLE: Senior Manager (OT/CSV) - Professional Service Operations
DEPARTMENT: Operations
REPORTS TO: Chief Operations Officer (COO)
CLASSIFICATION: Exempt (salary)
STATUS: Full Time
LOCATION: Varies Between Remote, at a Client Site in the US and at an office
cGMPnow accelerates Next Generation Therapies to patients by providing GxP Manufacturing & QC Laboratory Equipment, GxP Computerized Systems, Commissioning & Qualification, and Procurement services using project-dedicated expert resources.
With our unique project delivery methodology and owner-focused involvement, we bring new products to the market faster by providing cGMP systems faster.
POSITION SUMMARY:
The Senior Manager Professional Service Operations (PSO) is a technical leader responsible for management of staff within the Engineering workstreams and the implementation of GMP computerized systems in FDA & EU regulated. The PSO staff manage the scope, schedule, and budget as well as execute the technical engineering on capital projects to FDA & EU regulated Advanced Therapeutic industries.
The successful candidate will have experience managing and executing the implementation of GMP manufacturing and/or laboratory computerized systems under a GAMP/SDLC framework. Projects will range in size from simple off the shelf systems to large enterprise systems.
This role is both hands-on and leadership-oriented. This position will directly support active projects as a Senior Engineer.
COMPENSATION & BENEFITS:
Salary Compensation Range: $165,000 - $220,000 annual depending on years of relevant experience on a 40 hr/wk basis
Commission Potential Compensation Range: $0 - $50,000+ annual
This position is eligible for healthcare benefits with the employee premiums 100% paid for by the company, enrollment in a retirement savings plan with company contributions, company matching of charitable contributions, profit sharing and is eligible for paid time off.
Please note that the salary information is a general guideline only. Other factors such as (but not limited to) scope and responsibilities of the position, candidate's work experience, education/ training, key skills as well as market and business considerations when extending an offer.
REQUIREMENTS:
Bachelor’s degree in Chemical, Mechanical, Bioengineering, Architecture, Electrical, or related engineering discipline.
8+ years of experience as an engineer in GMP life-science environments
5+ years leading project teams and/or managing clients on capital projects within the Pharmaceutical, Biotech and Life Sciences Industries
3+ years of direct people management experience leading engineering teams
Experience with design and validation of process control systems including DeltaV and PLCs (such as Allen-Bradley ControlLogix), programming in ladder logic and instructional texts, and HMI screen development and management
Experience with design and validation of implementing and maintaining Windows-based Operations Technology control systems and related components including Active Directory, User Administration, Network Communication, and backup systems
Experience with design and validation of implementing QC lab systems (Empower, Softmax Pro, LabX, etc.) and associated LIMS that support advanced therapeutics
Knowledge and experience with facility design and manufacturing process in at least two of the following areas:
Advanced Therapeutics Medicinal Products (ATMPs), such as autologous & allogeneic cell therapy, gene therapy, viral vector, stem cells, mRNA, and plasmid modalities
Biologics and biopharmaceuticals, such as monoclonal antibodies (mAbs) or recombinant proteins
Large molecules, including mammalian cell culture (e.g., CHO cells), microbial fermentation, anti-body drug conjugates (ADCs), and downstream purification modalities
Small molecule therapeutics, such as chemical synthesis, crystallization, and Active Pharmaceutical Ingredient (API) production, drug product manufacture in solid oral dosage forms (tablets, capsules), including granulation, blending, tableting, and coating modalities
Familiar with ISPE Baseline Guides, EU/FDA regulations, cGMPs, and risk-based design methodologies
Excellent leadership, communication, and client-facing skills; able to influence decision-making at senior levels
Able to work in the US without sponsorship now or any time or in the future
ESSENTIAL RESPONSIBILITIES:
SUPERVISOR and MANAGER of PSO STAFF
Support Human Resources during the five employee life cycle phases for PSO workstream staff: recruiting, hiring, onboarding, employee engagement and separation of employment.
Provide supervision and management of Professional Service Operations workstream staff.
Conduct 1:1’s with PSO staff and support Human Resources during annual performance reviews.
Mentor and provide professional development guidance for the Professional Service Operations workstream staff.
QUALITY CONTROL and CONTINUOUS IMPROVEMENT
Develop and maintain best practices for Project Management & Engineering Design execution.
Oversee the Professional Service Operations execution across the cGMPnow portfolio of projects to ensure alignment with best practices.
Seek to improve overall execution strategy and skills of the Professional Service Operations workstream.
Support continuous improvement of tools, templates, workflows, and knowledge management.
PROFESSIONAL SERVICES OPS RESOURCE MANAGEMENT
Manage and/or support the allocation of all resources across the portfolio of projects to align to with productivity targets established by the COO.
Conduct or provide support to regularly occurring Professional Service Operations resource management meetings and the associated Professional Service Operations Resource Tracking Tool for tracking of employees and partner/subcontractor involvement on active projects.
Identify upcoming resource needs to Human Resources and support recruiting and hiring efforts.
Technical Design / Problem Solving:
Develop and revise CSV project plans, work breakdown structures and schedules.
Provide project management to integrators and/or other contractors/vendors to ensure project goals are met
Work closely with client project stakeholders (IT, System Owner, Engineering, QA) to effectively and efficiently implement new systems, system upgrades, or system modifications
Define requirements to procure and implement GMP computerized systems that are compliant with applicable GMP/Data Integrity/Data Security regulations and industry standards.
Develop, review and execute all computerized system life cycle documents (URS, Validation Plan, Specifications, Risk Assessment, Qualifications IQ/OQ/PQ, Data Integrity Evaluations, Trace Matrix, SOP’s, Validation Summary Report)
Support data integrity implementation and remediation for GMP computerized systems.
Develop and maintain a controls implementation/data integrity strategy that integrates process knowledge, equipment design, and quality standards with information technology to reduce downtime, elevate the level of regulatory compliance, and introduce efficiency gains through effective use of available technologies
SKILLS:
Strong candidate will possess the following key attributes:
Team player, hands-on attitude, willingness to be actively involved
Hard working, driven, results-oriented and focused on success
High ethical standards and integrity
Ability to perform work with little to no direction
Excellent oral and written communication
Personal computer and keyboarding
Critical thinking and problem solving
Time management, organizational and planning processes
Proficiency in staff management
Leadership & team development
Conceptual design excellence
GMP regulatory knowledge
Risk-based engineering decision-making
Client management & executive communication - Exemplary Customer service including attentive and active listening with management, employees, vendors and customers
Cross-disciplinary coordination
Capital cost & schedule planning
High-level strategic planning
Quality oversight & governance
KNOWLEDGE:
Operating standard office equipment including; personal computers, peripherals, and typical office equipment (telephone, copier, printers, scanners, etc.)
Microsoft Office Suite (Word, Outlook, PowerPoint, Excel) and other related software programs
Google Suite proficient
ABILITIES:
Highly skilled in managing multiple priorities and multi-tasking with frequent interruptions
Extremely flexible in times of change and can easily adapt to changing environments and priorities
Take initiative and plan ahead
Maintain a good attitude while working under pressure and defuse stressful situations
Work in a team environment and work effectively with other departments to accomplish goals
Work effectively and collaboratively with Directors of other workstreams
Works effectively with Officers of the company
Work independently with little or no supervision
Plan, conduct and attend meetings in person or via teleconference software
OTHER:
Willingness to travel locally, within 60 miles of residence, for full time support at client site
Willingness to travel outside of local area up to 30% of the time over a calendar year
All other duties as assigned
PHYSICAL REQUIREMENTS:
The position requires intermittent physical activity of sitting, standing, walking, bending, stooping, crouching and lifting up to 25 pounds on occasion. If you cannot do one of these physical requirements cGMPnow will make reasonable accommodations. Must be able to talk, write and understand the English language. Able to type/keyboard or enter data using a computer up to 8 hours per day. Must possess normal manual dexterity and eye-hand coordination.
cGMPnow is an Equal Opportunity Employer and Prohibits Discrimination and Harassment of Any Kind: cGMPnow is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment. All employment decisions are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. cGMPnow will not tolerate discrimination or harassment based on any of these characteristics.
The term “protected class” refers to groups of people who are legally protected from being harmed or harassed by laws, practices, and policies that discriminate against them due to a shared characteristic (e.g. race, gender, age, disability, or sexual orientation).
Disclaimer:
The preceding job description has been designed to indicate the general nature and level of work performed by the employee(s) within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees in this position. Job descriptions are not intended as and do not create employment contacts. The organization maintains its status as an at-will employer.
