The Manufacturing Technician II is accountable for results in a fast-paced environment and is responsible for manufacturing of drug products (parenteral or solid dosage) for commercial distribution and clinical trials. The Manufacturing Technician II operates manufacturing processing equipment by following standard operating procedures (SOPs) and batch records in accordance with regulatory agencies and current Good Manufacturing Practices (cGMPs). The Manufacturing Technician II employs acceptable techniques while working in manufacturing environments, including PPE gowning. The Manufacturing Technician II works collaboratively to support other manufacturing areas as required.$24k-35k yearly est.36d ago
Senior Manufacturing Technician
The Senior Manufacturing Technician is accountable for results in a fast-paced environment and is responsible for manufacturing of drug products (parenteral or solid dosage) for commercial distribution and clinical trials. The Senior Manufacturing Technician operates manufacturing processing equipment by following standard operating procedures (SOPs) and batch records in accordance with regulatory agencies and current Good Manufacturing Practices (cGMPs). The Senior Manufacturing Technician employs acceptable techniques while working in manufacturing environments, including PPE gowning. The Senior Manufacturing Technician demonstrates proficiency in all department procedures, trains and coaches other technicians, and provides work instruction and oversees daily work assignments in the absence of the supervisor as needed. The Senior Manufacturing Technician interacts with customers as needed.$43k-62k yearly est.60d+ ago
Manager, Pharmaceutical Manufacturing - 3rd Shift
The Manager, Manufacturing is accountable for driving results in a fast-paced environment by providing leadership to the site's manufacturing function. Focus areas for the role include operational leadership, parenteral (fill/finish, inspection) manufacturing process, project management, continuous improvement, change management, manufacturing investigations/corrective actions, participation in business reviews, and support of regulatory and client audits. The position requires superior leadership behaviors of the Alcami core competencies and non-negotiables, as well as expertise in functional competencies included in this position profile.
Essential Functions
* Develops information and produces reports concerning scheduling, production goals, equipment and maintenance problems and other studies or reports as requested.
* Provides manufacturing information by compiling, initiating, sorting, and analyzing production related records and data to key stakeholders within Alcami.
* Ensures all manufacturing discrepancies are captured with appropriate documentation and works collaboratively with appropriate personnel to facilitate client communication per quality agreements.
* Accountable for accurate and timely completion of all department investigation reports and the effective and timely corrective/preventative action (CAPA) implementations and follow-up.
* Accountable for the accurate and timely completion of all manufacturing processes and documentation (batch records) and "first time right" performance goals.
* Responsible for administration of department budget to include forecasting resources for future periods.
* 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 and a minimum of 8 years of related experience required.
* A minimum of 4 years of supervisory experience is required.
* Prior pharmaceutical experience, CMO or CDMO experience required.
* Aseptic filling experience required.
Alcami Non-Negotiables
* 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.
Functional Competencies
* Expert knowledge of review/approving manufacturing investigations ensuring they are completed in a timely manner with appropriate root cause analysis and effective corrective/preventive action identified required.
* Expert Knowledge of supporting the development of new or revised manufacturing instructions preferred.
* Knowledge of operational procedures for equipment preparation, formulation, filing, capping and lyophilization activities within their respective cGMP guidance/procedures required.
* Knowledge of leading manufacturing teams to maintain adherence to a demanding production schedule required.
Supervisory Responsibilities
* Directly leads team of 7-8 direct reports.
* Participates in the hiring process of other employees.
* Makes hiring decisions of other 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.
Travel Requirements
* Up to 5% domestic travel$84k-110k yearly est.2d ago
The Senior Project Engineer is accountable for driving superior results in a fast-paced environment by being responsible for multiple large capital related projects. The Senior Project Engineer will be responsible for managing multiple assigned projects including construction, process improvements, equipment installation and other capital projects while performing all related activities to ensure such efforts adhere to schedule, meet budget and accomplish the defined scope. This role is responsible for implementing and designing projects (capital, construction, utility, green initiatives, process improvement efforts) which includes working with cross-functional departments to understand the scope and needs of the project and developing the project implementation plan within budget and schedule guidelines. This professional reviews design for quality compliance, safety and adherence to company standards as well as customer contract requirements. This position will ensure the project accomplishes objectives by planning and evaluating project activities. The Senior Project Engineer will execute design responsibilities for some projects.
The Senior Project Engineer provides day-to-day performance monitoring and feedback and is responsible for full management of scoping, design, bid analysis and construction contractors, along with fiscal management of each project and a group of projects to meet financial and schedule targets. The Senior Project Engineer creates and maintains various reports and documents to measure the status of each of his/her projects. The Senior Project Engineer serves as the day-to-day manager of both small and high profile projects that are often complex, fast-track projects and often occurring while the buildings are occupied and operating. The Senior Project Engineer partners with executives, managers and staff to work on various aspects of planning, evaluating (cost/benefit), managing operational impacts of the project and evaluating ongoing operational aspects. The position requires superior leadership behaviors of the Alcami core competencies and non-negotiables, as well as expertise in functional competencies included in this position profile. Th Senior Project Engineer will be responsible for mentoring less tenured project engineering professionals, capable of providing guidance and mentorship in the execution of engineering projects and responsibilities.
Essential Functions
* Manages multiple projects (capital, construction, utility, green initiatives, etc). Oversees the project planning process, including developing a project implementation plan, collecting project requirements, defining the project scope, defining project activities, developing project activity sequencing, establishing activity resource needs, establishing activity durations, developing project schedules, developing cost estimates; developing communications and risk management plans. Determines project specifications, determines project phases and prepares cost estimates.
* Manages project from beginning to end:
* Identifies requirements, develops and prepares written project scope of work and other concept phase documents.
* Develops information necessary for RFP process, manages formal bid process and selection of contractors.
* Selects and works with consultants/A&E firms and/or equipment vendors to create project drawings and specifications as applicable.
* Often responsible for providing primary project design support for larger and more complex projects.
* Manages design review process and secures all applicable approvals.
* Provides value engineering expertise based on constructability, design expertise and calibrates design solutions.
* Reviews plans, specifications and submittals for new and remodeled building projects for code compliance and building standards.
* Participates in internal discussions with internal customers to determine timing for project execution and sequencing of various project milestones.
* Provides facilities and utilities support for new or modified equipment used to manufacture new active pharmaceutical ingredients.
* Requests bids from contractors and suppliers by working with procurement group; recommends best provider.
* Completes formal CAPEX document preparation and submission.
* Controls project plan and maintains project schedule by closely monitoring project progress, coordinating activities on critical path.
* Controls project costs by approving expenditures; administers contracts and monthly expenditures against planned cash flow.
* Prepares project status reports.
* Responsible for commissioning and coordinating of equipment/areas in preparation for validation activities.
* Maintains company reputation by complying with applicable federal and state regulations. Demonstrates company loyalty in relations with company personnel.
* Maintains a safe, clean and organized work environment free of safety hazards.
* Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
Education and Experience
* Bachelor's Degree in Engineering.
* Minimum 10 years' experience in engineering project planning/management.
* Previous work experience in a sterile manufacturing environment preferred.
* Automation and controls background preferred.
Alcami Non-Negotiables
* 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.
Functional Competencies
* Able to perform assigned tasks carefully and on schedule according to standard operating procedures and supervisor's instructions.
* Ability to work with people at all levels of the organization.
* Ability to perform complex math functions, compute ratios, rates and percentages.
* Ability to draw and interpret graphs and charts.
* Ability to solve practical problems and deal with a variety of concrete variables in situations where limited standardization exists.
* Ability to interpret a variety of instructions furnished in written, oral, diagram or schedule form.
* Excellent verbal communications and presentation skills required.
* Proficiency with Microsoft Office applications.
Decision Making and Supervision Required
* Applies job skills and company policies and SOPs to complete a broad range of difficult tasks.
* Receives minimal instruction on day-to-day work, general instructions on new assignments.
Travel Requirements
* Up to 5% domestic travel required.
Physical Demands and Work Environment
The physical demands and work environment 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 is regularly required to use hands to finger, handle, or feel; reach with hands and arms; talk or hear and smell. The employee is frequently required to sit. The employee is occasionally required to stand; walk and stoop, kneel, crouch, or crawl. The employee must 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, color vision, peripheral vision, depth perception and ability to adjust focus. The noise level is moderate to noisy. Occasionally, employee may be exposed to airborne particles and fumes. Occasionally, employee may be exposed to chemicals. Must have the ability to wear PPE as required. Employee occasionally may be exposed to moving mechanical parts and vibration.
Other Duties
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.$72k-98k yearly est.20d ago
Director, Manufacturing Quality Operations
The Director, Quality Operations is accountable for driving results in a fast paced environment by continously challenging the performance of quality standards, systems and opertating procedures. The Director, Quality provides leadership to the site Quality team who perform quality review and approval of documents, data, protocols, qualifications, change controls, deviations, investigations, complaints, corrective action activities (CAPAs), and quality audits and inspections. This leader develops short and long-range goals, metrics, and objectives; directs the implementation of quality plans and works with lab management to ensure department goals and objectives are met. The Director, Quality interacts with clients and regulatory agencies regarding quality issues, audits and inspections.
Essential Functions
* Ensures GMP compliance to regulatory requirements and Company procedures.
* Collaborates with corporate quality functions to ensure site compliance with the company's Quality Management Systems (QMS).
* Oversees QMS to ensure timely closure of deviations, investigations, corrective actions, etc.
* Conducts thorough root-cause analysis for investigations.
* Implements corrective and preventive actions to eliminate repeat observations.
* Guides, instructs, and coaches members of management in compliance issues.
* Supports regulatory inspections to ensure minimal observations.
* Engages in client audits and client interactions.
* Writes responses to regulatory and client audit reports.
* Develops and implements systems to aid in efficiency and compliance improvements for the site.
* Develops short and long-range goals and objectives for the site quality function.
* Develops, implements and maintains internal auditing program.
* Ensures controlled documentation is generated, revised, approved and maintained per corporate and regulatory agency procedures.
* 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, Biology, Microbiology) required; master's degree preferred.
* 8-12 years of related experience required, 12+ years preferred.
* 10+ years of pharmaceutical quality experience in Aseptic processing Environmental Monitoring required; 5+ years of management experience required.
* Prior pharmaceutical experience required; prior CDMO experience preferred.
* Prior experience with controlled substance reporting and handling, final product release, major equipment validation, validation protocol review, process validation protocol review and APRs preferred.
Alcami Non-Negotiables
* 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.
Functional Competencies
* Expert knowledge of pharmaceutical regulatory requirements and cGMP required.
* Knowledge of quality systems and processes, change control, CAPA and data integrity required.
* Knowledge of aseptic processing of commercial or clinical parenteral required for parenteral site(s).
* Knowledge of auditing preferred.
* Excellent skills in leadership, coaching and influencing others, strategic planning, critical thinking and problem solving, root-cause analysis and written communication and presentation skills required.
Supervisory Responsibilities
* Directly leads team of approximately 3-5 direct reports.
* Indirectly leads team of approximately 15-20.
* Participates in the hiring process of other employees.
* Makes hiring decisions of other 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
* Uses professional concepts and critical thinking to solve complex problems.
* Independently determines methods and procedures, including assignments and the work of others.
Travel Requirements
* Up to 10% domestic travel
Physical Demands and Work Environment
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 is required to frequently talk or hear. The employee is required some of the time to stand, walk, and sit. The employee is required to occasionally use hands to finger, handle, or feel; climb or balance; stoop, knell, crouch or crawl; reach with hands and arms; taste or smell. The employee must regularly lift and/or move up to 10 pounds, occasionally lift and/or move up to 50 pounds. There is no special vision requirement for this job. The employee may occasionally work in wet or humid conditions, near moving mechanical parts, in high precarious places, near fumes, airborne particles or toxic chemicals.
Other Duties
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.$98k-129k yearly est.50d ago
