(MST) and Process Engineering Department resides in Spark’s Patient Supply Organization. This role reports into the MST arm of the department where the key MST group responsibilities are to support the development and manufacturing of gene therapies, starting with their transition into clinical manufacturing and continuing through the remainder of the product lifecycle.
This comprises of, but is not limited to, process fit evaluation, tech transfer, person-in-plant support, investigation of deviations, late-stage process development, data analysis, process validation and annual production reporting, all for both internal and external manufacturing. The MST Lab team carries out wet-lab
experimentation necessary to support the efforts described above for late-phase and commercial programs. Scope and complexity of studies vary greatly. Duration will span from single-day one-off experiments to year-long projects composed of multiple experimental sets.
The types of work include: process scale up, support and trouble shooting process and material characterization process validation studies small-scale model development and qualification control strategy development investigation support to close deviations (non-conformance) technology development and technology transfer (TT) driven by product lifecycle requirements raw material qualification and characterization process
technology development and integration Responsibilities Design and execute process studies.
Document results in laboratory notebooks, presentations and in technical documents Serve as an AAV drug substance manufacturing process subject matter expert (SME) as needed during various types of activities, such as manufacturing deviation investigations, risk backssments, facility design, equipment evaluations, and technology transfer Monitor and evaluate technologies related to efficient, robust and scalable bioprocess technologies Routinely interface with partner lines: Manufacturing, Process Development, Quality Assurance and Control and Supply Chain Author Standard Operating Procedures (SOPs) for laboratory equipment Assist Engineering, Facilities and Maintenance teams with the troubleshooting and maintenance of laboratory equipment.
Lead or support manufacturing deviation investigations As needed, be present at CMOs & CDMOs to monitor execution of manufacturing steps and studies, as well provide technical guidance as needed. Support authoring and preparation of content for regulatory documents, interactions, and inspections Support initiatives to streamline MS&T processes Manage individual performance to achieve business goals and objectives, as well as, ongoing professional development.
Manage performance: K now what is expected, what it takes to be successful, and self-monitor progress. Be accountable to achieve results while demonstrating the Spark Values. Periodically review individual objectives to ensure alignment to corporate and functional objectives, making adjustments if priorities have shifted. Commit to collaborate. Be a strong team player and business partner cross functionally. Understand the development goals, strengths and motivators of your colleagues and partner to achieve mutual success and continuous improvement as well as professional development.
Foster Spark’s Culture, Mission, Vision, and Values: Lead by example. Create an environment where team members thrive in our Culture by living our truths, always in compliance with applicable laws and regulations. Emphasize to employees that “how” they achieve performance objectives is just as important as “what” they accomplish. Education and Experience Requirements Required Experiences BS/MS/Ph D in Life Science/Engineering or related field required. Minimum 4 years of Biotechnology and/or medical experience Hands-on cell culture bioreactor and/or microbial fermentor operation Thorough understanding of upstream bioprocessing scientific and engineering principles Working knowledge of downstream bioprocessing scientific and engineering principles Experience in designing experiments Demonstrated technical project management experience to develop project goals, deliverables, timelines, budget management and ongoing prioritization.
Up to 20% travel Preferred Experiences Hands-on filtration (direct and tangential flow) and chromatography experience Experience in biomedical based GMP manufacturing science and technology; direct experience in upstream and/or downstream development or production environments.
Proven track record of contributions to manufacturing technology platform development, in a GLP/GMP Pilot Plant and/or development lab facility Experience with accelerated CMC development pathways a plus Knowledge of GXP compliance Spark takes into consideration a combination of candidate’s education, training, and experience as well as the position’s scope and complexity, the discretion and latitude required in the role, and external market and internal value when determining a salary for potential new employees. The base salary range for this position is currently from $95,800 to $143,600.
Spark Therapeutics does not accept unsolicited resumes/candidate profiles from any source other than directly from candidates. Any unsolicited resume/candidate profile submitted through our website or to personal email accounts of employees of Spark Therapeutics are considered property of Spark Therapeutics and are not subject to payment of agency fees.
is our priority, and the success of our railroad is due to our employees. Are you ready to join our team? Our values of ‘Do the Right Thing, Excel Together and Put Customers First’ are at the heart of what matters most to us, and our Core Capabilities, ‘Building Trust, Accountability, Effective Communication, Customer Focus, and Proactive Safety & Security’ are what every employee needs to know and do to be most impactful at Amtrak.
By living the Amtrak values, focusing on our capabilities, and actively embracing and fostering diverse ideas, backgrounds, and perspectives, together we will honor our past and make Amtrak a company of the future. SUMMARY OF DUTIES: The number one goal of
this position is to provide a safe and reliable railroad transportation signal system. This position is responsible for and provides engineering for the complex projects and studies required to repair, rehabilitate, or construct Amtrak Communication & Signal/PTC facilities and systems.
This position provides technical expertise to other departments and makes engineering decisions for the C&S Department and their staff upon request. Participates in the development of standard procedures and practices to be used in signal design/PTC. Participates in the development of standard contract documents used in the design of signals/PTC. This position is responsible for design of circuits and software
for railroad signal systems (switch machine control circuits, home networks, energy loops, relay racks) for interlockings, highway crossings, automatic signal locations, cut sections, and electric lock locations to ensure compliance with Federal and Amtrak’s standards and policies using Microstation.
Participates in project design meeting, reviews SOW, and provides detailed comments. ESSENTIAL FUNCTIONS: Must be capable of developing solutions to individual circuit problems. Maintains documentation of all comments regarding of plans, both internal and external. Assist field personnel in handling problems encountered during signal cutovers and is responsible to revise design plans to reflect as-in-service changes or modifications.
Assists field personnel in performing quality control pre-testing on signal systems/PTC. Attends simulation, factory pretest, cut overs, and assists in the development of these procedures. Prepares aspect charts to show the signal orientation. Ensures C&S/PTC design files database is currently and properly maintained. MINIMUM QUALIFICATIONS: Bachelor’s degree in Electrical Engineering Demonstrate experience in signal design/PTC, technical supervision, technical design, design software, project management, railroad maintenance, and construction methods and planning / scheduling.
Strong working knowledge of railroad signal circuit plan symbols, nomenclature, and circuit logic. Working knowledge of railroad circuit design as applied in signal systems/PTC. Working knowledge of circuit and signal design/PTC practices of predecessor railroads. Knowledge of C&S/PTC equipment (relay racks, batteries, etc. ) Knowledge of how to calculate braking distances of trains. Knowledge of mathematics and Boolean algebra as it applies to relay logic. Knowledge of how to translate computer programming into circuit plans or relay logic.
Knowledge of FRA standards, rules, and regulations. Knowledge of software system design concepts, and processes. Must be qualified on NORAC, AMT-2 and RWP. Prior satisfactory job performance is required. MINIMUM KSA (Knowledge, Skills and Abilities): Demonstrated experience in communication orally and in writing within and outside of the organization. Ability to communicate with field personnel to ensure accuracy of signal system designs/PTC on file. Ability to shift priorities at short notice Ability to organize and plan work Ability to coach and mentor others Analyze situations and problems Knowledge of Federal regulations and directives Ability to function in a stressful environment PREFERRED QUALIFICATIONS: Master’s degree in Electrical Engineering with eight years relevant experience or twelve years equivalent combination of education, training and experience Extensive experience in writing and checking railroad train control software programs.
Extensive field knowledge of train control construction and maintenance practices. Experience using Bentley Microstation Applications. Qualified on NORAC, AMT-2 and RWP 6 years relevant experience or ten years equivalent combination of education, training and experience.
Knowledge of Amtrak’s interlocking layouts and physical characteristics. WORK ENVIRONMENT: Combination of office and field work. Must be able to work in the field under all weather conditions. Travel: (25%). COMMUNICATIONS AND INTERPERSONAL SKILLS: Must have excellent oral and written communication skills. The salary/hourly range is $103,700 - $134,460. Pay is based on several factors including but not limited to education, work experience, certifications, internal equity, etc. Depending on an employee’s assigned worksite or location, Amtrak may consider a geo-pay differential to be applied to the employee’s base salary.
Amtrak may offer additional incentive and pay programs to recognize and reward our employees, including a short-term incentive bonus based upon factors such as individual and company performance that is commensurate with the level of the position and/or long-term incentive plan compensation. In addition to your salary, Amtrak offers a comprehensive benefit package that includes health, dental, and vision plans; health savings accounts; wellness programs; flexible spending accounts; 401K retirement plan with employer match; life insurance; short and long term disability insurance; paid time off; back-up care; adoption assistance; surrogacy assistance; reimbursement of education expenses; Public Service Loan Forgiveness eligibility; Railroad Retirement sickness and retirement benefits; and rail pass privileges.
Learn more about our benefits offerings here. Requisition ID: 160495 Posting Location(s): Pennsylvania Job Family/Function: Engineering Relocation Offered: No Travel Requirements: Up to 25% You power our progress through your performance. We want your work at Amtrak to be more than a job. We want your career at Amtrak to be a fulfilling experience where you find challenging work, rewarding opportunities, respect among colleagues, and attractive compensation.
Amtrak maintains a culture that values high performance and recognizes individual employee contributions. Amtrak is committed to a safe workplace free of drugs and alcohol. All Amtrak positions requires a pre-employment background check that includes prior employment verification, a criminal history check and a pre-employment drug screen. Candidates who test positive for marijuana will be disqualified, regardless of any state or local statute, ordinance, regulation, or other law that legalizes or decriminalizes the use or possession of marijuana, whether for medical, recreational, or other use.
Amtrak's pre-employment drug testing program is administered in accordance with DOT regulations and applicable law. In accordance with DOT regulations (49 CFR § 40.25), Amtrak is required to obtain prior drug and alcohol testing records for applicants/employees intending to perform safety-sensitive duties for covered Department of Transportation positions. If an applicant/employee refuses to provide written consent for Amtrak to obtain these records, the individual will not be permitted to perform safety-sensitive functions.
In accordance with federal law governing security checks of covered individuals for providers of public transportation (Title 6 U. S. C. §1143), Amtrak is required to screen applicants for any permanent or interim disqualifying criminal offenses. Note that any education requirement listed above may be deemed satisfied if you have an equivalent combination of education, training and experience. Amtrak is an EOE/Affirmative Action Minority/Female employer, and we welcome all to apply. We consider candidates regardless of race/color, religion, interaction (including pregnancy, childbirth and related conditions), national origin/ethnicity, age, disability (intellectual, mental and physical), veteran status, marital status, ancestry, interactionual orientation, gender identity and gender expression, genetic information, citizenship or any other personal characteristics protected by law.
